title: A Multicentre, Multinational, Randomised, Open-labelled, Parallel-group, Active-controlled Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency

acronym: REAL 2

summary: This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in previously human growth hormone (hGH) treated adults with growth hormone deficiency.

lead_sponsor: Novo Nordisk A/S

location_country:
Sweden
France
Japan
Denmark
Germany
United Kingdom


title: An Open Label Study Examining the Efficacy and Cardiovascular Risk of Immediate Versus Deferred Switch From a Boosted PI to Dolutegravir (DTG) in HIV Infected Patients With Stable Virological Suppression

summary:
The purpose of the study is to investigate the benefits of switching away from a kind of drug called a boosted protease inhibitor (PI) to a new drug called dolutegravir on patients' cardiovascular health (the health of their hearts). Patients are currently taking two other anti-HIV drugs, called nucleoside reverse transcriptase inhibitors (NRTIs), with their boosted PIs; these NRTIs will not be changed throughout the study. In order to compare the boosted PI and dolutegravir more accurately, half of study participants will be switched to dolutegravir immediately, and the other half will be switched after 48 weeks of continuing on the boosted PI.

Boosted PIs are associated with increased heart and circulation risk so it is hoped that switching from a boosted PI to dolutegravir will improve the health of the patients' hearts. Dolutegravir is a drug for HIV treatment which has been approved for use in HIV patients in the US and Europe. Clinical trials using dolutegravir have found that it is effective at suppressing the HIV virus, and it is at least as effective as the other drugs.

This study will also investigate the safety (in terms of other side effects and the routine blood tests which the investigators ordinarily use to monitor patients' treatment) and monitor effectiveness, patients' viral load and CD4 counts, when patients switch treatment from a boosted PI to dolutegravir. Viral load is the amount of the HIV virus they have in their blood, and CD4 count is a measure of a type of cell that is in their immune system. We also aim to improve patients' cardiovascular health in general by providing them with information on how to live a healthy lifestyle (eg improving their diet, stopping smoking etc).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gatell JM, Assoumou L, Moyle G, Waters L, Johnson M, Domingo P, Fox J, Martinez E, Stellbrink HJ, Guaraldi G, Masia M, Gompels M, De Wit S, Florence E, Esser S, Raffi F, Stephan C, Rockstroh J, Giacomelli A, Vera J, Bernardino JI, Winston A, Saumoy M, Gras J, Katlama C, Pozniak AL; European Network for AIDS Treatment 022 (NEAT022) Study Group. Immediate Versus Deferred Switching From a Boosted Protease Inhibitor-based Regimen to a Dolutegravir-based Regimen in Virologically Suppressed Patients With High Cardiovascular Risk or Age ≥50 Years: Final 96-Week Results of the NEAT022 Study. Clin Infect Dis. 2019 Feb 1;68(4):597-606. doi: 10.1093/cid/ciy505.

name: Hospital Clinic/Institut d’Investigacions Biomediques August Pi i Suñer, University of Barcelona and ViiV Healthcare, Spain

family: Gatell

full_name: José M Gatell

given: José M

sequence: first

name: Institut national de la santé et de la recherche médicale (INSERM), Sorbonne Université, Institut Pierre Louis d’épidémiologie et de Santé Publique, Unite Medical pour la Recherche Scientifique 1136, Paris, France

family: Assoumou

full_name: Lambert Assoumou

given: Lambert

sequence: additional

name: Chelsea and Westminster Hospital and St Stephens AIDS Trust, London, United Kingdom

family: Moyle

full_name: Graeme Moyle

given: Graeme

name: Mortimer Market Center, London, United Kingdom

family: Waters

full_name: Laura Waters

given: Laura

name: Royal Free Hospital, London, United Kingdom

family: Johnson

full_name: Margaret Johnson

given: Margaret

family: Domingo

full_name: Pere Domingo

given: Pere

name: Guys and St Thomas` Hospital, London, United Kingdom

family: Fox

full_name: Julie Fox

given: Julie

family: Martinez

full_name: Esteban Martinez

given: Esteban

name: Infektionsmedizinisches Study Centrum, Hamburg, Germany

family: Stellbrink

full_name: Hans-Jürgen Stellbrink

given: Hans-Jürgen

name: University of Modena and Reggio Emilia, Modena, Italy

family: Guaraldi

full_name: Giovanni Guaraldi

given: Giovanni

family: Masia

full_name: Mar Masia

given: Mar

name: Southmead Hospital, Bristol, United Kingdom

family: Gompels

full_name: Mark Gompels

given: Mark

name: Saint Pierre Hospital, Université Libre de Bruxelles, Brussels

family: De Wit

full_name: Stephane De Wit

given: Stephane

name: Institute of Tropical Medicine, Antwerp, Belgium

family: Florence

full_name: Eric Florence

given: Eric

family: Esser

full_name: Stefan Esser

given: Stefan

name: Infectious Diseases University Hospital and Centre d’Investigation Clinique, Unite d’Investigation Clinique 1413 INSERM, Centre Hopitalier Universitaire Nantes, France

family: Raffi

full_name: François Raffi

given: François

name: Klinikum der Goethe Universitat, Frankfurt

family: Stephan

full_name: Christoph Stephan

given: Christoph

name: Medizinische Klinik und Poliklinik, Bonn, Germany

family: Rockstroh

full_name: Juergen Rockstroh

given: Juergen

family: Giacomelli

full_name: Andrea Giacomelli

given: Andrea

name: Global Health and Infection, Brighton and Sussex Medical School, United Kingdom

family: Vera

full_name: Jaime Vera

given: Jaime

family: Bernardino

full_name: José Ignacio Bernardino

given: José Ignacio

name: St Mary’s Hospital, London, United Kingdom

family: Winston

full_name: Alan Winston

given: Alan

family: Saumoy

full_name: Maria Saumoy

given: Maria

family: Gras

name: Pitie-Salpetriere Hospital, Paris, France

repository_institution: University of Sussex - Sussex Research Online

title: Immediate Versus Deferred Switching From a Boosted Protease Inhibitor–based Regimen to a Dolutegravir-based Regimen in Virologically Suppressed Patients With High Cardiovascular Risk or Age ≥50 Years: Final 96-Week Results of the NEAT022 Study

location_country:
Italy
France
Belgium
Spain
Germany
United Kingdom

location_facility: Klinikum der Goethe-Universität Frankfurt

location_facility: Azienda Ospedaliera - Polo Universitario 'Luigi Sacco'

location_facility: Service des Maladies Infectieuses et Tropicales du CHU de NANTES


title: International, Multicenter, Randomized, Non-comparative Controlled Study of Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients With Long-term Viral Suppression

summary: Viral eradication in selected HIV-infected patients is possible with intensive antiretroviral therapy plus immunomodulation

ReferenceType: background

ReferenceCitation: Murphy RL, Autran B, Katlama C, Brucker G, Debre P, Calvez V, Clotet B, Clumeck N, Costagliola D, Deeks SG, Dorrell L, Gatell J, Haase A, Klein M, Lazzarin A, McMichael AJ, Papagno L, Schacker TW, Wain-Hobson S, Walker BD, Youle M. A step ahead on the HIV collaboratory. Science. 2009 Jun 5;324(5932):1264-5. doi: 10.1126/science.324_1264b.

ReferenceCitation: Lewin SR, Rouzioux C. HIV cure and eradication: how will we get from the laboratory to effective clinical trials? AIDS. 2011 Apr 24;25(7):885-97. doi: 10.1097/QAD.0b013e3283467041. Review.

ReferenceCitation: Lafeuillade A. Eliminating the HIV reservoir. Curr HIV/AIDS Rep. 2012 Jun;9(2):121-31. doi: 10.1007/s11904-012-0115-y. Review.

ReferenceCitation: Cohen J. The emerging race to cure HIV infections. Science. 2011 May 13;332(6031):784-5, 787-9. doi: 10.1126/science.332.6031.784.

ReferenceCitation: Lewin SR, Evans VA, Elliott JH, Spire B, Chomont N. Finding a cure for HIV: will it ever be achievable? J Int AIDS Soc. 2011 Jan 24;14:4. doi: 10.1186/1758-2652-14-4.

ReferenceCitation: Katlama C, Lambert-Niclot S, Assoumou L, Papagno L, Lecardonnel F, Zoorob R, Tambussi G, Clotet B, Youle M, Achenbach CJ, Murphy RL, Calvez V, Costagliola D, Autran B; EraMune-01 study team. Treatment intensification followed by interleukin-7 reactivates HIV without reducing total HIV DNA: a randomized trial. AIDS. 2016 Jan;30(2):221-30. doi: 10.1097/QAD.0000000000000894.

family: Katlama

full_name: Christine Katlama

given: Christine

family: Lambert-Niclot

full_name: Sidonie Lambert-Niclot

given: Sidonie

family: Assoumou

full_name: Lambert Assoumou

given: Lambert

family: Papagno

full_name: Laura Papagno

given: Laura

family: Lecardonnel

full_name: François Lecardonnel

family: Zoorob

full_name: Rima Zoorob

given: Rima

family: Tambussi

full_name: Giuseppe Tambussi

given: Giuseppe

family: Clotet

full_name: Bonaventura Clotet

given: Bonaventura

family: Youle

full_name: Mike Youle

given: Mike

family: Achenbach

full_name: Chad J. Achenbach

given: Chad J.

family: Murphy

full_name: Robert L. Murphy

given: Robert L.

family: Calvez

full_name: Vincent Calvez

given: Vincent

family: Costagliola

full_name: Dominique Costagliola

given: Dominique

family: Autran

full_name: Brigitte Autran

given: Brigitte

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: AIDS

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Objectif Recherche Vaccins SIDA

location_country:
Italy
United Kingdom
France
Spain

location_facility:
San Raffaele Scientific Institute
Royal Free Hospital
Groupe Hospitalier Pitié-Salpêtrière
University Hospital Clinic of Barcelona
Fundacio Irsicaixa

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: An Open Label, Non-randomized, Phase I Dose Escalation Study to Characterize Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY1163877 in Subjects With Refractory, Locally Advanced or Metastatic Solid Tumors

summary:
This was the first study where BAY1163877 was given to humans. Impact of the study was to evaluate if patients with advanced solid cancers show advanced clinical benefit under the treatment with the pan FGFR inhibitor. Patients (all comers) received the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1163877. The relative bioavailability of liquid service formulation and tablets was determined.
After the MTD was defined patients with solid tumors (all comers), lung cancer (lung adenocarcinoma & squamous non-small cell lung cancer), head and neck cancer or bladder cancer was enrolled according to their FGFR expression profile (biomarker stratification).
The study also assessed the pharmacokinetics, biomarker status, pharmacodynamic parameters and tumor response of BAY1163877.
BAY1163877 was given twice daily as oral application. Treatment was stopped if the tumor continued to grow, if side effects, which the patient cannot tolerate, occurred or if the patient decided to exit treatment.

study_start_date_type: Actual

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Schuler M, Cho BC, Sayehli CM, Navarro A, Soo RA, Richly H, Cassier PA, Tai D, Penel N, Nogova L, Park SH, Schostak M, Gajate P, Cathomas R, Rajagopalan P, Grevel J, Bender S, Boix O, Nogai H, Ocker M, Ellinghaus P, Joerger M. Rogaratinib in patients with advanced cancers selected by FGFR mRNA expression: a phase 1 dose-escalation and dose-expansion study. Lancet Oncol. 2019 Oct;20(10):1454-1466. doi: 10.1016/S1470-2045(19)30412-7. Epub 2019 Aug 9.

family: Schuler

full_name: Martin Schuler

given: Martin

family: Cho

full_name: Byoung Chul Cho

given: Byoung Chul

family: Sayehli

full_name: Cyrus Michael Sayehli

given: Cyrus Michael

family: Navarro

full_name: Alejandro Navarro

given: Alejandro

family: Soo

full_name: Ross A Soo

given: Ross A

family: Richly

full_name: Heike Richly

given: Heike

family: Cassier

full_name: Philippe Alexandre Cassier

given: Philippe Alexandre

family: Tai

full_name: David Tai

given: David

family: Penel

full_name: Nicolas Penel

given: Nicolas

family: Nogova

full_name: Lucia Nogova

given: Lucia

family: Park

full_name: Se Hoon Park

given: Se Hoon

family: Schostak

full_name: Martin Schostak

family: Gajate

full_name: Pablo Gajate

given: Pablo

family: Cathomas

full_name: Richard Cathomas

given: Richard

family: Rajagopalan

full_name: Prabhu Rajagopalan

given: Prabhu

family: Grevel

full_name: Joachim Grevel

given: Joachim

family: Bender

full_name: Sebastian Bender

given: Sebastian

family: Boix

full_name: Oliver Boix

given: Oliver

family: Nogai

full_name: Hendrik Nogai

given: Hendrik

family: Ocker

full_name: Matthias Ocker

given: Matthias

family: Ellinghaus

full_name: Peter Ellinghaus

given: Peter

family: Joerger

full_name: Markus Joerger

given: Markus

ReferenceCitation: Grünewald S, Politz O, Bender S, Héroult M, Lustig K, Thuss U, Kneip C, Kopitz C, Zopf D, Collin MP, Boemer U, Ince S, Ellinghaus P, Mumberg D, Hess-Stumpp H, Ziegelbauer K. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer. 2019 Sep 1;145(5):1346-1357. doi: 10.1002/ijc.32224. Epub 2019 Mar 13.

title: Rogaratinib: A potent and selective pan‐FGFR inhibitor with broad antitumor activity in FGFR‐overexpressing preclinical cancer models

location_country:
United States
Switzerland
France
Singapore
Spain
Germany
Korea, Republic of


title: Renvela® Post-Marketing Observational Study to Monitor the Clinical Use in Adult Hyperphosphataemic Chronic Kidney Disease Patients Not On Dialysis With Serum Phosphorus ≥1.78 mmol/L

summary: The primary objective of this study is to assess in a post-approval clinical setting the safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of Product Characteristics (SmPC) and followed according to the investigator's standard clinical practice management. Each patient will be followed up for 12 months or up to the time they start dialysis, whichever occurs first.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Genzyme, a Sanofi Company

location_country: Italy Austria Netherlands France Spain Denmark Germany


title: Validation of an EORTC Quality of Life Questionnaire Module for Patients With Colorectal Cancer

summary:
RATIONALE: Collecting information about the quality of life of patients with colorectal cancer may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying the European Organization of Research for the Treatment of Cancer (EORTC) quality-of-life-questionnaire in patients with colorectal cancer.

enrollment_type: Anticipated

ReferenceCitation: Arraras JI, Suárez J, Arias de la Vega F, Vera R, Asín G, Arrazubi V, Rico M, Teijeira L, Azparren J. The EORTC Quality of Life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients. Clin Transl Oncol. 2011 Jan;13(1):50-6. doi: 10.1007/s12094-011-0616-y.

family: Arraras

full_name: Juan Ignacio Arraras

given: Juan Ignacio

family: Suárez

full_name: Javier Suárez

given: Javier

family: Arias de la Vega

full_name: Fernando Arias de la Vega

given: Fernando

family: Vera

full_name: Ruth Vera

given: Ruth

family: Asín

full_name: Gemma Asín

given: Gemma

family: Arrazubi

full_name: Virginia Arrazubi

given: Virginia

family: Rico

full_name: Mikel Rico

given: Mikel

family: Teijeira

full_name: Lucía Teijeira

given: Lucía

family: Azparren

full_name: Jaione Azparren

given: Jaione

journal_name: Clinical and Translational Oncology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: The EORTC quality of life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients

ReferenceCitation: Nowak W, Tobiasz-Adamczyk B, Brzyski P, Sałówka J, Kuliś D, Richter P. Adaptation of quality of life module EORTC QLQ-CR29 for Polish patients with rectal cancer: initial assessment of validity and reliability. Pol Przegl Chir. 2011 Sep;83(9):502-10. doi: 10.2478/v10035-011-0078-5.

family: Nowak

full_name: Wojciech Nowak

given: Wojciech

family: Tobiasz-Adamczyk

full_name: Beata Tobiasz-Adamczyk

given: Beata

family: Brzyski

full_name: Piotr Brzyski

given: Piotr

family: Sałówka

full_name: Jerzy Sałówka

given: Jerzy

family: Kuliś

full_name: Dagmara Kuliś

given: Dagmara

family: Richter

full_name: Piotr Richter

journal_name: Polish Journal of Surgery

publisher: Index Copernicus

publisher_dissemination: Index Copernicus

publisher_group: Index Copernicus

publisher_normalized: Index Copernicus

title: Adaptation of Quality of Life Module EORTC QLQ-CR29 for Polish Patients with Rectal Cancer - Initial Assessment of Validity and Raeliability

ReferenceCitation: Whistance RN, Conroy T, Chie W, Costantini A, Sezer O, Koller M, Johnson CD, Pilkington SA, Arraras J, Ben-Josef E, Pullyblank AM, Fayers P, Blazeby JM; European Organisation for the Research and Treatment of Cancer Quality of Life Group. Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer. 2009 Nov;45(17):3017-26. doi: 10.1016/j.ejca.2009.08.014. Epub 2009 Sep 16.

family: Whistance

full_name: R.N. Whistance

family: Conroy

full_name: T. Conroy

given: T.

family: Chie

full_name: W. Chie

given: W.

family: Costantini

full_name: A. Costantini

given: A.

family: Sezer

location_facility: Basingstoke and North Hampshire NHS Foundation Trust

location_facility: Charite University Medical Center of Berlin


title: Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL.

summary: To evaluate the safety and efficacy of R-COMP in elderly patients with advanced aggressive NHL. Myocet (non-pegylated liposomal doxorubicin) replaces conventional doxorubicin in the R-CHOP regimen.

status: Unknown status

lead_sponsor: Zeneus Pharma

location_country:
Italy
France
Spain
Germany
United Kingdom

location_facility: Universita Degli Studi Di Modena AZ Ospedaliere Policlinico

status_simplified: Unknown


intervention_type: Other

status: Terminated

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
United States
France

ipd_sharing: Yes

source: euctr

title: A Randomized, Open Label, Controlled, Multiple Dose Study to Evaluate the Clinical Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LFG316 in Patients With Transplant Associated Microangiopathy After Hematopoietic Precursor Cell Transplantation

summary:
This was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM after hematopoietic precursor cell transplantation (HPCT) .

Study consisted of up to 28 days of screening period, 16 weeks treatment period that can be extended to 45 weeks.Approximately 40 patients was to be randomized to receive SoC or LFG316 plus SoC. Patients was included in the study if they have diagnosis of TAM and poor prognostic markers. This trial was terminated: LFG316, a monoclonal antibody inhibitor of complement factor 5 (C5), had been studied in seven patients with transplantation-associated microangiopathy (TAM). Due to low confidence of clinical benefit, this study was closed


title: Open-Label Multicenter 2-Arm Phase I Study of RO5429083 With Dose-Escalation and Extension Cohorts, and Imaging Cohorts With RO5429083 and 89Zr-labeled RO5429083, in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

summary: This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
France
Netherlands


title: EPO906 Phase I 6-arm Trial to Optimize Administration Exploring Single Dose Bolus and Continuous Infusion Over 1 or 5 Days Every 3 or 4 Weeks in Patients With Pretreated Advanced Colon Cancer With Nutritional Support Treatment and Intensive Management of Diarrhea

summary: This study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with pretreated advanced colon cancer.

location_country:
United Kingdom
France
Czechia
Spain


title: A Randomised, Open-label, Multicentre, Phase 3 Trial of First-line Treatment With Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects With Steroid-refractory Acute Graft-versus-host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)

acronym: IDUNN

summary: The primary purpose of this trial is to demonstrate the superiority of MC0518 compared to the first used best available therapy (BAT) with respect to overall response rate (ORR) in adult and adolescent participants with steroid-refractory acute graft-versus-host disease (SR-aGvHD) at Day 28.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: medac GmbH

location_country: Spain Germany France Poland

location_facility:
Mannheim
Tuebingen, Baden-Wuerttemberg
Koeln, North Rhine-Westphalia
Hannover, Niedersachsen
Dresden
Nice
Valencia
Leipzig, Saxony
Rennes
Frankfurt am Main, Hessen
Tuebingen
Freiburg
Barcelona
Essen, North Rhine-Westphalia
Bonn
Jena, Thüringen
Wroclaw
Vandoeuvre les Nancy
Lille
Pierre Benite Cedex
Mainz
Muenster, Nordrhein-Westfalen
Madrid
Munich, Bavaria
Berlin, Berlin
Frankfurt
Grenoble Cedex
Wuerzburg

intervention_type: Biological

status_simplified: Ongoing


type: Other Identifier

title: Metacognition in Semantic Dementia: Comparison With Alzheimer's Disease

acronym: META-DEM

summary: This study aims at exploring patients' ability to monitor their own memory performance depending on their primary deficit and the type of memory involved in the criterion task. The goal is to evaluate if semantic dementia (SD) and Alzheimer's disease (AD) differently affect patients' awareness of their memory abilities.

lead_sponsor: University Hospital, Grenoble

location_country: France Switzerland

location_facility:
CHU Angers
Hôpital Neurologique de Lyon
CHU Bordeaux
Chu Grenoble Alpes
CHU Rennes
CHU Vaudois
Hôpitaux Civils Colmar

lead_sponsor_type: academique


title: A PHASE 1, MULTICENTRE, OPEN-LABEL, DOSE-ESCALATION AND COHORT EXPANSION STUDY OF NIRAPARIB AND DOSTARLIMAB IN PAEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMOURS

acronym: SCOOP

summary: This study will evaluate the combination of a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, niraparib, with the programmed cell death protein 1 (PD-1) inhibitor, dostarlimab in the pediatric population. This study will be conducted to determine the recommended Phase 2 dose (RP2D) and evaluate the pharmacokinetics (PK), safety, and efficacy of niraparib in combination with dostarlimab in pediatric participants with recurrent or refractory solid tumors.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country: France Spain


title: A Comparative Study of Pravastatin vs Placebo as Primary Prevention of Severe Subcutaneous Breast Fibrosis in Hyper-radiosensitive Identified Patients With Breast Cancer

summary:
-Interventional trials aim at preventing severe RIF occurrence in BC patients selected by individual radiosensitivity:

PRAVAPREV-01 will be the first interventional double blind trial that will offer a personalised strategy to breast cancer patients who will be treated with adjuvant RT after breast conserving surgery:

By assessing individual risk of severe RIF development
By offering a statin targeted therapy to the high-risk patients identified.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_country: Monaco France

location_facility: Centre Hospitalier Universitaire Lyon Sud


title: ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes

acronym: ADAPT

summary: The purpose of this study evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) system in sub-optimally controlled patients with T1D, in comparison with Multiple Daily Injection (MDI) therapy with Flash Glucose Monitoring (FGM) or Continuous Glucose Monitoring (CGM). Patient with a diagnosis of Type 1 diabetes currently under MDI+ FGM or MDI+ CGM therapy will be enrolled.

status: Active, not recruiting

lead_sponsor: Medtronic Diabetes

location_country:
Germany
United Kingdom
France

location_facility: Harrogate and District Hospital - NHS Foundation Trust

location_facility: Medical Center am Clemenshospital Dr. Winfried Keuthage

location_facility: University Hospitals of Leicester NHS Trust Leicester General Hospital

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Gemeinschaftspraxis im Westtor Hausarztpraxis & Diabetologische Schwerpunktpraxis

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz

location_facility: Diabetologische Schwerpunktpraxis Dr. Ralf Kolassa


title: Understanding the Long-Term Management of Organic Acidemia Patients With CARBAGLU®: A Mixed Methods Approach

acronym: PROTECT

summary: This is a prospective mixed-design study focused on the long-term management of propionic aciduria (PA) and methylmalonic aciduria (MMA) with N-carbamylglutamate (NCG) maintenance therapy. Treatment characteristics, clinical outcomes, and healthcare utilization data of patients diagnosed PA or MMA treated >6 months therapy with NCG are collected at baseline, 12 months, and 18 months. Qualitative interviews with adult patients and caregivers are conducted >6 months after study enrollment to gain a better understanding of the disease burden and the treatment burden of patients and their families.

lead_sponsor: Recordati Rare Diseases

location_country:
Italy
France
Norway
Spain
United Kingdom

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: San Paola Hospital, ASST Santi Paolo e Carlo

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hopital Des Enfants, CHU de Bordeaux-GH Pellegrin

location_facility: Guy's and St. Thomas' Hospital NHS Foundation Trust

location_facility: Sheffield Children's Hospital NHS Foundation Trust


title: SHAMAL: A Multicentre, Randomised, Open-Label, Parallel-Group, Active-Controlled, Phase IV Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

summary: This is a multicentre, randomised, open-label, parallel-group, active-controlled, phase IV study to assess the reduction of daily Symbicort® maintenance to anti-inflammatory reliever treatment only in participants with severe eosinophilic asthma on Fasenra® treatment, while maintaining asthma control.

ReferenceCitation: Butler CA, Heaney LG. Fractional exhaled nitric oxide and asthma treatment adherence. Curr Opin Allergy Clin Immunol. 2021 Feb 1;21(1):59-64. doi: 10.1097/ACI.0000000000000704. Review.

family: Butler

full_name: Claire A. Butler

given: Claire A.

family: Heaney

full_name: Liam G. Heaney

given: Liam G.

journal_name: Current Opinion in Allergy & Clinical Immunology

ipd_sharing: Undecided

lead_sponsor: AstraZeneca

location_country:
Italy
Germany
United Kingdom
France


title: Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Sirolimus-eluting Coronary Stent System in the Treatment of All-comer Patients With Coronary Artery Disease

summary: This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex arm of the TALENT trial) and demonstrate that the Supraflex Cruz stent is not inferior to the BioFreedom stent in High Bleeding Risk (HBR) patients (400 patients) with respect to device oriented composite endpoint (DOCE) at 12 months. All patients will be followed up to 12 months after the index procedure.

lead_sponsor: Sahajanand Medical Technologies Pvt. Ltd.

location_country: Germany France Switzerland

location_facility: Heart and Diabetes Center Nordrhine Westfalia

location_facility: Herzzentrum Dresden - Universitätklinikum an der TU Dresden

location_facility: Städtische Kliniken Neuss, Lukaskrankenhaus

intervention_type: Device


title: An Open-label, Single Arm, Multi-centre, Phase II Study Investigating Safety, Tolerability, Efficacy, Pharmacodynamics and Pharmacokinetics of Imlifidase in Patients With Guillain-Barré Syndrome, in Comparison With Matched Control Patients

summary:
The study participants are patients which have been diagnosed with Guillain-Barré Syndrome (GBS) and are planned to receive treatment with intravenous immunoglobulin (IVIg). IVIg is a standard of care treatment for GBS patients. The patients in this study will be treated with the study medicine imlifidase on day 1, and with IVIg on days 3-7.

The purpose of this study is to investigate the safety and effectiveness of imlifidase in patients diagnosed with GBS.

lead_sponsor: Hansa Biopharma AB

location_country:
United Kingdom
France
Netherlands

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Queen Elizabeth University Hospital Glasgow

location_facility: CHU Bordeaux - Hôpital Pellegrin Tripode

location_facility: CHU de Montpellier, Hôpital Gui de Chauliac

location_facility: CHU Le Kremlin-Bicêtre. Service Neurologie

location_facility: Hôpital de la Timone - Centre de référence des maladies neuromusculaires et de la SLA


lead_sponsor: Gilead Sciences

location_country:
Moldova, Republic of
Romania
Russian Federation
France

location_facility: Moscow Regional Scientific and Research Clinical Institute

location_facility: "Matei Bals" National Institute of Infectious Diseases, Hospital department

location_facility: Specialized clinical Infectious diseases Hospital

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Federal Budget Institute of Science "Central Research Institute for Epidemiology" of Federal Service on Consumers Rights Protection and Human Well-Being Surveillance

location_facility: "Victor Babes" Centre of Diagnostic and Treatment

location_facility: Federal State Budgetary Institution National Research Medical Center for Phthisiopulmonology and Infectious Diseases of the Ministry of Health of the Russian Federation

location_facility: Hôpital Cochin - Unité d'Hépatologie Pavillon Achard

location_facility: CH Pitié-Salpétrière - Hépato-Gastroentérologie

location_facility: State Budgetary Educational Institution of Higher Professional Education "South Ural State Medical University" of the Ministry of Healthcare of the Russian Federation

location_facility: "Matei Bals" National Institute of Infectious Diseases,Clinical Trials department

location_facility: Infectious Clinical Hospital "T. Ciorba", Department 5 / Medical University Department of Infectious Diseases

location_facility: N.V.Sklifosovsky Scientific Research Institute of Emergency care of the Moscow Healthcare Department

location_facility: Dr. V. Babes Clinical Hospital of Infectious and Tropical Diseases

location_facility: Hôpital Beaujon-Pavillon Abrami -Sce Hépatologie

location_facility: Hôpital Saint Joseph Hépato-Gastroentérologie

location_facility: Infectious Clinical Hospital "T. Ciorba", Department 4 / Medical University Department of Infectious Diseases

title: A Multicenter, Open-label, Randomized Phase 2b Clinical Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Patients With Chronic Hepatitis Delta

summary: The primary objective of this study is to evaluate the efficacy of bulevirtide combination with pegylated interferon in participants with chronic hepatitis delta (CHD).


title: International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.

acronym: PALMIRA

summary: Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)

ipd_sharing_description: Study Leaflet V2_20190115 with study design, primary objetive, inclusion criteria and exclusion criteria

lead_sponsor: MedSIR

location_facility: Klinikum Mutterhaus der Borromäerinnen Trier

location_facility: Hospital Regional Universitario de Malaga

location_facility: Policlinico Universitario Campus Bio-medico

location_facility: Abertawe Bro Morgannwg University Local Health Board, Singleton Hospital

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Hospital General Universitari de Valencia


title: HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk

summary: Multicenter feasibility study of the HighLife™ TMVR system.

ReferenceCitation: Lange R, Piazza N. HighLife transcatheter mitral valve replacement. EuroIntervention. 2016 Sep 18;12(Y):Y81-3. doi: 10.4244/EIJV12SYA22. Review.

ReferenceCitation: Stone GW, Adams DH, Abraham WT, Kappetein AP, Généreux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015 Jul 21;66(3):308-321. doi: 10.1016/j.jacc.2015.05.049.

ReferenceCitation: Barbanti M, Piazza N, Mangiafico S, Buithieu J, Bleiziffer S, Ronsivalle G, Scandura S, Giuffrida A, Popolo Rubbio A, Mazzamuto M, Sgroi C, Lange R, Tamburino C. Transcatheter Mitral Valve Implantation Using the HighLife System. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1662-1670. doi: 10.1016/j.jcin.2017.06.046.

lead_sponsor: HighLife SAS

location_country: Germany France

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie

location_facility: Universitäres Herzzentrum Hamburg GmbH (UHZ)


ipd_sharing_description: All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Netherlands
Poland
France
Spain
Germany
United Kingdom

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Royal Marsden Hospital - Chelsea, London

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

title: Maintenance Therapy With Trabectedin Versus Observation After First Line Treatment With Doxorubicin of Patients With Advanced or Metastatic Soft Tissue Sarcoma.

summary:
Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma.

This is a prospective, multicenter, randomized, open label Phase III trial investigating whether a maintenance treatment with trabectedin, as compared to the observational approach, can prolong progression-free survival in patients with advanced, inoperable and/or metastatic STS after response or stabilisation during first line treatment with doxorubicin.


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety, Efficacy and Pharmacodynamic Study of Basmisanil (RO5186582) in Adults With Severe Motor Impairment Following an Ischemic Stroke

summary: This Phase IIa, randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with severe motor impairment following an ischemic stroke.

location_facility: Hôpital General - Service de neurologie; Service de neurologie

location_facility: Hospital Clnico Universitario de Zaragoza

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: Hôpital Pellegrin Tripode - CHU de Bordeaux

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B


title: Evaluation of Safety and Performance of the Neuroform AtlasTM Stent System for Intracranial Aneurysm Treatment - Post Market Clinical Follow-up

acronym: ATLAS EU PMCF

summary: The primary objective of this study is to demonstrate effectiveness and safety of the NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial aneurysm treatment.

ReferenceCitation: Lefevre PH, Schramm P, Kemmling A, Barreau X, Marnat G, Piotin M, Berlis A, Wanke I, Bonafe A, Houdart E; ATLAS EU PMCF Investigators. Multi-centric European post-market follow-up study of the Neuroform Atlas Stent System: primary results. J Neurointerv Surg. 2021 Sep 2. pii: neurintsurg-2021-017849. doi: 10.1136/neurintsurg-2021-017849. [Epub ahead of print]

family: Lefevre

full_name: Pierre-Henri Lefevre

given: Pierre-Henri

family: Schramm

full_name: Peter Schramm

given: Peter

family: Kemmling

full_name: André Kemmling

given: André

family: Barreau

full_name: Xavier Barreau

given: Xavier

family: Marnat

full_name: Gaultier Marnat

given: Gaultier

family: Piotin

full_name: Michel Piotin

given: Michel

family: Berlis

full_name: Ansgar Berlis

given: Ansgar

family: Wanke

full_name: Isabel Wanke

given: Isabel

family: Bonafe

full_name: Alain Bonafe

given: Alain

family: Houdart

full_name: Emmanuel Houdart

given: Emmanuel

journal_name: Journal of NeuroInterventional Surgery

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Stryker Neurovascular

location_country: Slovakia Germany France


title: Phase III, Randomised, Double Blind, Placebo Controlled and Open Label Phase Multicentre Study to Investigate the Efficacy and Safety of BTX-A-HAC NG in the Treatment of Moderate to Severe Glabellar Lines, and Assess the Long Term Efficacy and Safety of BTX-A-HAC NG Following Repeated Treatments in This Indication

summary: The purpose of the protocol is to demonstrate the safety and the efficacy of a single injection of a new formulation of Clostridium Botulinum toxin type A haemagglutinin complex (BTX A HAC NG) to improve the appearance of moderate to severe glabellar lines (the lines between the eyebrows) and to assess the long term efficacy and safety of BTX-A-HAC NG after repeated injections.

lead_sponsor: Ipsen

location_facility: MEDITI/ Clinique Science et Beauté, Villa Sylvana

location_facility: Privatpraxis für Dermatologie und ästhetische Medizin

location_facility: Privatpraxis für Dermatologie und Ästhetik

location_facility: Abteilung Biochemie und Molekularbiologie Fachrichtung Kosmetikwissenschaft

location_facility: Universitäts-Hautklinik der Gutenberg Universität Mainz


title: International, Multicentre, Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM Study I10E-1302"

summary:
Primary objective:

To assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP response after an initial 6-month treatment in PRISM study. (I10E-1302).

Secondary objective:

To assess the safety of I10E in this patient population.

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

location_country:
Italy
France
Tunisia
Spain
Turkey
United Kingdom

location_facility: Uludag University Medical School Neurology

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Hacettepe University medical School Neurology

location_facility: Marmara Universitesi Egitim Ve Arastirma Hastanesi

location_facility: istanbul University Cerrahpasa Medical School Neurology

location_facility: Hospital Universitario i Politècnico La Fe

location_facility: Azienda Ospedaliera Universitaria san Giovanni

location_facility: IRRCS Istutito Nazionale Neurologico Besta

location_facility: University Hospital of North Straffordshire

location_facility: Ankara university medical school Neurology

location_facility: Azienda Ospedaliera Universitaria di Padova


title: The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence

acronym: EASY

summary: This is a prospective, post-market, single arm, multicenter study comparing Baseline data to the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence

lead_sponsor: Coloplast A/S

location_country: Italy Netherlands France Spain Germany

location_facility: Chirurgische Klinik München - Bogenhausen GmbH

location_facility: Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle

location_facility: Centre Hospitalier Universitaire Carémeau - Gyneacology


title: An Open-label, Multicentre Study to Evaluate the Immunogenicity and Safety of One Dose of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older Without a Previous Diphtheria- and Tetanus-containing Booster Within the Last 20 Years

summary:
Primary objective:

To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects

Secondary objectives:

If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
To describe the immune responses to REPEVAX in these subjects
To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects

primary_purpose: Prevention

lead_sponsor: Sanofi Pasteur, a Sanofi Company


ReferenceCitation: Llombart-Cussac A, Bermejo B, Villanueva C, Delaloge S, Morales S, Balmaña J, Amillano K, Bonnefoi H, Casas A, Manso L, Roché H, Gonzalez-Santiago S, Gavilá J, Sánchez-Rovira P, Di Cosimo S, Harbeck N, Charpentier E, Garcia-Ribas I, Radosevic-Robin N, Aura C, Baselga J. SOLTI NeoPARP: a phase II randomized study of two schedules of iniparib plus paclitaxel versus paclitaxel alone as neoadjuvant therapy in patients with triple-negative breast cancer. Breast Cancer Res Treat. 2015 Nov;154(2):351-7. doi: 10.1007/s10549-015-3616-8. Epub 2015 Nov 4.

family: Llombart-Cussac

full_name: Antonio Llombart-Cussac

given: Antonio

family: Bermejo

full_name: Begoña Bermejo

given: Begoña

family: Villanueva

full_name: Cristian Villanueva

given: Cristian

family: Delaloge

full_name: Suzette Delaloge

given: Suzette

family: Morales

full_name: Serafín Morales

given: Serafín

family: Balmaña

full_name: Judith Balmaña

given: Judith

family: Amillano

full_name: Kepa Amillano

given: Kepa

family: Bonnefoi

full_name: Hervé Bonnefoi

given: Hervé

family: Casas

full_name: Ana Casas

given: Ana

family: Manso

full_name: Luis Manso

given: Luis

family: Roché

full_name: Henri Roché

given: Henri

family: Gonzalez-Santiago

full_name: Santiago Gonzalez-Santiago

given: Santiago

family: Gavilá

full_name: Joaquín Gavilá

given: Joaquín

family: Sánchez-Rovira

full_name: Pedro Sánchez-Rovira

given: Pedro

family: Di Cosimo

full_name: Serena Di Cosimo

given: Serena

family: Harbeck

full_name: Nadia Harbeck

given: Nadia

family: Charpentier

full_name: Eric Charpentier

given: Eric

family: Garcia-Ribas

full_name: Ignacio Garcia-Ribas

given: Ignacio

family: Radosevic-Robin

full_name: Nina Radosevic-Robin

given: Nina

family: Aura

full_name: Claudia Aura

given: Claudia

family: Baselga

full_name: Jose Baselga

given: Jose

journal_name: Breast Cancer Research and Treatment

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

location_facility:
Investigational Site Number 276001
Investigational Site Number 724013
Investigational Site Number 250004
Investigational Site Number 250005
Investigational Site Number 724017
Investigational Site Number 250002
Investigational Site Number 724018
Investigational Site Number 724009
Investigational Site Number 250001
Investigational Site Number 724015
Investigational Site Number 724016
Investigational Site Number 276004
Investigational Site Number 724001
Investigational Site Number 250006
Investigational Site Number 724011
Investigational Site Number 724010
Investigational Site Number 724006
Investigational Site Number 250003
Investigational Site Number 724003
Investigational Site Number 724005
Investigational Site Number 724007
Investigational Site Number 276003
Investigational Site Number 276002
Investigational Site Number 724012
Investigational Site Number 724002

title: Randomized, Open-label, Phase 2 Study of the Efficacy and Safety of Weekly Paclitaxel Single-agent and Two Different Regimens of the PARP-1 Inhibitor SAR240550 (BSI-201) in Combination With Weekly Paclitaxel, as Neoadjuvant Therapy in Patients With Stage II-IIIA Triple Negative Breast Cancer (TNBC)

summary:
Primary Objective:

- to assess the pathological Complete Response (pCR) rate in the breast of patients treated in following combinations: SAR240550 twice-weekly + weekly paclitaxel, SAR240550 weekly+ weekly paclitaxel, and weekly paclitaxel single agent as calibrator.

Secondary objectives are:

pCR rate in the breast and axilla,
Radiological/clinical objective response rate (ORR), breast conservation rate, disease free survival (DFS), and overall survival (OS), in each treatment arm,
Safety profiles of study combinations and of the single agent reference treatment,
Molecular characteristics of the tumor tissue and peripheral blood mononuclear cells (PBMC) and any correlation between the biological activity of the study treatment and the disease outcome.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.


title: A Double-Blind, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus

summary: Patients will continue to use their current insulin pump for this study. Patients will receive insulin lispro and insulin aspart during this study. One medication will be taken for 12 weeks and then the other medication for 12 weeks. Neither the patient nor the study doctor will know which medication is being taken at any time. The order in which the two medications are taken will be determined by chance.

lead_sponsor: Eli Lilly and Company

location_country: Germany Hungary France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Plerixafor and G-CSF for the Mobilisation of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) - Safety Study in a General Autologous Transplant Population

acronym: PREDICT

summary: This is a research study intended to further investigate the safety and efficacy of plerixafor in patients with NHL, HD, or MM. Patients who have previously failed stem cell mobilisation attempts or who have previously received more than one autologous or any allogeneic stem cell transplant are not eligible.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
Sweden
Netherlands
France
Spain
Germany
United Kingdom

location_facility: L. & A. Seragnoli, University of Bologna


ReferenceCitation: Casper C, Carnielli VP, Hascoet JM, Lapillonne A, Maggio L, Timdahl K, Olsson B, Vågerö M, Hernell O. rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):61-9. doi: 10.1097/MPG.0000000000000365.

family: Casper

full_name: Charlotte Casper

given: Charlotte

family: Carnielli

full_name: Virgilio P. Carnielli

given: Virgilio P.

family: Hascoet

full_name: Jean-Michel Hascoet

given: Jean-Michel

family: Lapillonne

full_name: Alexandre Lapillonne

given: Alexandre

family: Maggio

full_name: Luca Maggio

given: Luca

family: Timdahl

full_name: Kristina Timdahl

given: Kristina

family: Olsson

full_name: Birgitta Olsson

given: Birgitta

family: Vågerö

full_name: Mårten Vågerö

given: Mårten

family: Hernell

full_name: Olle Hernell

given: Olle

journal_name: Journal of Pediatric Gastroenterology & Nutrition

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

title: rhBSSL Improves Growth and LCPUFA Absorption in Preterm Infants Fed Formula or Pasteurized Breast Milk

lead_sponsor: Swedish Orphan Biovitrum

location_country: Italy France

acronym: BVT. BSSL - 021

location_facility: Policlinico Universitario-Azienda Ospedeliero di Padova, Dipartimento di Pediatria

location_facility: CHRU de Tours, Centre de Pédiatrie Gatien de Clocheville

location_facility: Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M. Lancisi-G.Salesi"

title: A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Pasteurized Breast Milk Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

summary: The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.


title: Transplantation d'îlots pancréatiques allogéniques Adultes Pour le Traitement du diabète insulinodépendant. Etude GRAGIL 1

summary: This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.

ReferenceCitation: Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tétaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.

family: Lablanche

full_name: Sandrine Lablanche

given: Sandrine

family: Borot

full_name: Sophie Borot

given: Sophie

family: Wojtusciszyn

full_name: Anne Wojtusciszyn

given: Anne

family: Bayle

full_name: Francois Bayle

given: Francois

family: Tétaz

full_name: Rachel Tétaz

given: Rachel

family: Badet

full_name: Lionel Badet

given: Lionel

family: Thivolet

full_name: Charles Thivolet

given: Charles

family: Morelon

full_name: Emmanuel Morelon

given: Emmanuel

family: Frimat

full_name: Luc Frimat

given: Luc

family: Penfornis

full_name: Alfred Penfornis

given: Alfred

family: Kessler

full_name: Laurence Kessler

given: Laurence

family: Brault

full_name: Coralie Brault

given: Coralie

family: Colin

full_name: Cyrille Colin

given: Cyrille

family: Tauveron

full_name: Igor Tauveron

given: Igor

family: Bosco

full_name: Domenico Bosco

given: Domenico

family: Berney

full_name: Thierry Berney

given: Thierry

family: Benhamou

full_name: Pierre-Yves Benhamou

given: Pierre-Yves

journal_name: Diabetes Care

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

lead_sponsor: University Hospital, Grenoble

location_country: France Switzerland

location_facility: University Hospital, Department of Endocrinology

location_facility: University Hospital, Department of Surgery

intervention_type: Procedure


lead_sponsor: Bayer

location_country:
Italy
France
Poland
Germany
United Kingdom

title: A Phase II, Multi-centre, Open-label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Intrapatient Dose Escalation of Sorafenib as First Line Treatment for Metastatic Renal Cell Carcinoma.

summary:
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth of kidney cancer tumors.

This is an "open-label" study which means that the patient, the doctor and Bayer Healthcare will know what tablets the patient is taking. All patients in this study will receive sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day). Treatment with sorafenib will continue until the patient's tumor grows larger or spreads further or if the patient has intolerable side effects. The dose of sorafenib that the patient will receive in the study will increase at certain points during the patient's treatment, as long as the patient is not experiencing side effects and the patient's tumor has not grown.


ReferenceCitation: Heise T, Tack CJ, Cuddihy R, Davidson J, Gouet D, Liebl A, Romero E, Mersebach H, Dykiel P, Jorde R. A new-generation ultra-long-acting basal insulin with a bolus boost compared with insulin glargine in insulin-naive people with type 2 diabetes: a randomized, controlled trial. Diabetes Care. 2011 Mar;34(3):669-74. doi: 10.2337/dc10-1905. Epub 2011 Feb 1.

family: Heise

full_name: T. Heise

given: T.

family: Tack

full_name: C. J. Tack

given: C. J.

family: Cuddihy

full_name: R. Cuddihy

given: R.

family: Davidson

full_name: J. Davidson

given: J.

family: Gouet

full_name: D. Gouet

given: D.

family: Liebl

full_name: A. Liebl

given: A.

family: Romero

full_name: E. Romero

given: E.

family: Mersebach

full_name: H. Mersebach

given: H.

family: Dykiel

full_name: P. Dykiel

given: P.

family: Jorde

full_name: R. Jorde

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

title: A New-Generation Ultra-Long-Acting Basal Insulin With a Bolus Boost Compared With Insulin Glargine in Insulin-Naive People With Type 2 Diabetes: A randomized, controlled trial

ReferenceCitation: Ma Z, Parkner T, Christiansen JS, Laursen T. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012 Nov;12(11):1533-40. doi: 10.1517/14712598.2012.722203. Epub 2012 Sep 4. Review.

family: Ma

full_name: Zhulin Ma

given: Zhulin

family: Parkner

full_name: Tina Parkner

given: Tina

family: Christiansen

full_name: Jens Sandahl Christiansen

given: Jens Sandahl

family: Laursen

full_name: Torben Laursen

given: Torben

journal_name: Expert Opinion on Biological Therapy

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Liebl A, Davidson J, Mersebach H, Dykiel P, Tack CJ, Heise T. A novel insulin combination of insulin degludec and insulin aspart achieves a more stable overnight glucose profile than insulin glargine: results from continuous glucose monitoring in a proof-of-concept trial. J Diabetes Sci Technol. 2013 Sep 1;7(5):1328-36.

title: A 16 Week Randomised, Open Labelled, 3 Armed, Parallel Group, Treat-to-target Trial Comparing Once Daily Injection of SIAC 30 (B), SIAC 45 (B) and Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

summary: This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.


ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country: Germany France Spain

title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years

summary: In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.


title: Multicentric Prospective, Randomised, Controlled Clinical Study on Clinical Efficacy and Tolerability of Urinary FSH (Fostimon® , IBSA) Versus r-FSH (Gonal-F®, Serono) in ICSI.

summary: Purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs Gonal-F® Serono) when administered in patients undergoing ICSI

ReferenceCitation: GEMZELL CA, DICZFALUSY E, TILLINGER G. Clinical effect of human pituitary follicle-stimulating hormone (FSH). J Clin Endocrinol Metab. 1958 Dec;18(12):1333-48.

ReferenceCitation: Thompson CR, Hansen LM. Pergonal (menotropins): a summary of clinical experience in the induction of ovulation and pregnancy. Fertil Steril. 1970 Dec;21(12):844-53.

ReferenceCitation: Oelsner G, Serr DM, Mashiach S, Blankstein J, Snyder M, Lunenfeld B. The study of induction of ovulation with menotropins: analysis of results of 1897 treatment cycles. Fertil Steril. 1978 Nov;30(5):538-44.

ReferenceCitation: Schwartz M, Jewelewicz R, Dyrenfurth I, Tropper P, Vande Wiele RL. The use of human menopausal and chorionic gonadotropins for induction of ovulation. Sixteen years' experience at the Sloane Hospital for Women. Am J Obstet Gynecol. 1980 Dec 1;138(7 Pt 1):801-7.

ReferenceCitation: Notation AD, Tagatz GE, Steffes MW. Serum 17beta-estradiol. Index of follicular maturation during gonadotropin therapy. Obstet Gynecol. 1978 Feb;51(2):204-9.

ReferenceCitation: Doré PC, Rice C, Killick S. Human gonadotrophin preparations. May cause allergic reaction. BMJ. 1994 Jun 4;308(6942):1509.

ReferenceCitation: Howles CM, Loumaye E, Giroud D, Luyet G. Multiple follicular development and ovarian steroidogenesis following subcutaneous administration of a highly purified urinary FSH preparation in pituitary desensitized women undergoing IVF: a multicentre European phase III study. Hum Reprod. 1994 Mar;9(3):424-30.

ReferenceCitation: Wikland M, Borg J, Hamberger L, Svalander P. Simplification of IVF: minimal monitoring and the use of subcutaneous highly purified FSH administration for ovulation induction. Hum Reprod. 1994 Aug;9(8):1430-6.

ReferenceCitation: Daya S, Gunby J. Recombinant versus urinary follicle stimulating hormone for ovarian stimulation in assisted reproduction. Hum Reprod. 1999 Sep;14(9):2207-15.

ReferenceCitation: Remorgida V, Venturini PL, Anserini P, Lanera P, De Cecco L. Administration of pure follicle-stimulating hormone during gonadotropin-releasing hormone agonist therapy in patients with clomiphene-resistant polycystic ovarian disease: hormonal evaluations and clinical perspectives. Am J Obstet Gynecol. 1989 Jan;160(1):108-13.

ReferenceCitation: Hackelöer BJ, Fleming R, Robinson HP, Adam AH, Coutts JR. Correlation of ultrasonic and endocrinologic assessment of human follicular development. Am J Obstet Gynecol. 1979 Sep 1;135(1):122-8.

ReferenceCitation: Venturoli S, Paradisi R, Fabbri R, Magrini O, Porcu E, Flamigni C. Comparison between human urinary follicle-stimulating hormone and human menopausal gonadotropin treatment in polycystic ovary. Obstet Gynecol. 1984 Jan;63(1):6-11.

ReferenceCitation: Mendelson EB, Bohm-Velez M, Joseph N, Neiman HL. Gynecologic imaging: comparison of transabdominal and transvaginal sonography. Radiology. 1988 Feb;166(2):321-4.

ReferenceCitation: Fleischer AC. Transabdominal and transvaginal sonography of ovarian masses. Clin Obstet Gynecol. 1991 Jun;34(2):433-42. Review.

ReferenceCitation: Wang CF, Gemzell C. The use of human gonadotropins for the induction of ovulation in women with polycystic ovarian disease. Fertil Steril. 1980 May;33(5):479-86.

lead_sponsor: IBSA Institut Biochimique SA

location_country: Hungary France

location_facility:
Hôpital Edouard Herriot
Semmelweis Medical School
Private Consulting
Hôpital Tenon
Institut de Médecine de la Reproduction
Hôpital Jeanne de Flandre
Hôpital Américain


title: Multicenter, Dose Response, Randomized, Double Blind, Parallel, Placebo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of Subcutaneous CDP870 in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy

summary: A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.

ReferenceCitation: Ortonne JP, Tasset C, Reich K. Efficacy of certolizumab pegol, a PEGylated Fab' fragment of an anti-alpha monoclonal antibody, in patients previously exposed to biologicals: preliminary results of a randomised, placebo-controlled, phase II clinical trial in psoriasis. J.Eur.Acad.Dermatol.Venereol. 22[Suppl 1], 2007. Vienna, 16th Congress of the European Academy of Dermatology and Venereology (EADV), May 16-20, 2007.

ReferenceCitation: Ortonne JP, Sterry W, Tasset C, Reich K. Safety and efficacy of subcutaneous certolizumab pegol, a new anti-TNF-alpha monoclonal antibody, in patients with moderate-to-severe chronic plaque psoriasis: preliminary results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 56[Suppl 2], AB6. 2007. Washington, DC, 65th Annual Meeting of the American Academy of Dermatology (AAAD), February 2-7, 2007.

ReferenceCitation: Reich K, Tasset C, Ortonne J. Efficacy and safety of certolizumab pegol, in patients with chronic plaque psoriasis: preliminary results of a randomized, double-blind, placebo-controlled trial. Ann.Rheum.Dis. 66[Suppl 2], 251. 2007. Barcelona, Annual European Congress of Rheumatology EULAR 2007, June 13-16, 2007.

ReferenceCitation: Ortonne JP, Sterry W, Tasset C, Reich K. Certolizumab pegol, the first pegylated anti-TNF alpha, is effective and well tolerated in patients with moderate-to-severe chronic plaque psoriasis: preliminary data from a phase II study. J.Eur.Acad.Dermatol.Venereol. 21[Suppl 1], 26. 2007. Rhodes, Greece, 15th Congress of the European Academy of Dermatology and Venereology (EADV), October 4-8, 2006.

ReferenceCitation: Ortonne JP, Sterry W, Coteur G, Keininger DL, Reich K. Improved health-related quality of life in psoriasis patients following 10 weeks' treatment with certolizumab pegol: data from a Phase II study. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.

ReferenceCitation: Reich K, Sterry W, Tasset C, Terpstra I, Ortonne JP. Efficacy and time to relapse with certolizumab pegol, the first pegylated anti-TNF alpha agent, in patients with moderate-to-severe chronic plaque psoriasis: Phase II study results. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.

ReferenceCitation: Ortonne JP, Reich K, Sterry W, Terpstra I. Safety and efficacy (PASI 90 and global evaluation) of subcutaneous certolizumab pegol in patients with moderate to severe chronic plaque psoriasis: Results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 58[Suppl 2], AB4. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.

ReferenceCitation: Ortonne JP, Reich K, Keininger DL. Certolizumab pegol improved health-related quality of life in patients with psoriasis: Data from a phase II study. J.Am.Acad.Dermatol. 58[Suppl 2], AB121. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.

ReferenceCitation: Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012 Jul;167(1):180-90. doi: 10.1111/j.1365-2133.2012.10941.x. Epub 2012 Jun 11.

family: Reich

full_name: K. Reich

given: K.

family: Ortonne

full_name: J.-P. Ortonne

family: Gottlieb

full_name: A.B. Gottlieb

family: Terpstra

full_name: I.J. Terpstra

family: Coteur

full_name: G. Coteur

given: G.

family: Tasset

full_name: C. Tasset

given: C.

family: Mease

full_name: P. Mease

journal_name: British Journal of Dermatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab′ certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension

lead_sponsor: UCB Pharma


lead_sponsor: Pierre Fabre Medicament

primary_purpose: Supportive Care

location_country: Italy Germany France Spain

acronym: TOLAK

location_facility: Sapienza University of Rome - Polo Pontino

location_facility: Catholic University Fondazione Policlinico Universitario A. Gemelli

location_facility: NAPLES VANVITELLI UNIVERSITI (Federico II Hospital)

location_facility: Kath. Klinikum Bochum St. Josef-Hospital

title: Frequency and Intensity of Local Reactions in Patients Treated With 4% 5-FU vs 4% 5-FU Associated With an Emollient Cream: a Randomised, Controlled Clinical Trial

summary:
Transient local skin reactions with topical Actinic Keratosis treatments such as 5-FluoroUracil (5-FU) often lead to non-adhesion from patients and thus to treatment failure. In regards to 5-FU treatment, these local reactions are related to the pharmacological action of the molecule. The current therapeutic challenge is to reduce the local reactions induced by 5-FU without interfering with its efficacy, in particular by the use of an emollient cream.

The aim of the present study is to investigate how the use of an emollient, namely Dexeryl, could improve the local skin reactions occurring during 4 weeks of a 4% 5-FU treatment (Tolak).


title: TEMOkids Study: A Population Pharmacokinetic, Acceptability and Safety Study for KIMOZO, a Paediatric Oral Suspension of Temozolomide

summary: Non-randomized, international, multi-centre, open-label, single arm study to determine the pharmacokinetic (PK) parameters of a single dose of an oral suspension of temozolomide (KIMOZO) in the pediatric population aged 1 year and over.

lead_sponsor: Orphelia Pharma

location_country:
Netherlands
France
Spain
Germany
United Kingdom

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique

location_facility: Princess Maxima Center for Pediatric Oncology

location_facility: Hopp Children's Cancer Center Heidelberg


title: AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy

summary: Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing

primary_purpose: Other

lead_sponsor: University Hospital, Rouen

location_country: France Spain

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Universitario y Politécnico La Fe


ReferenceCitation: Ramanan AV, Guly CM, Keller SY, Schlichting DE, de Bono S, Liao R, Quartier P. Clinical effectiveness and safety of baricitinib for the treatment of juvenile idiopathic arthritis-associated uveitis or chronic anterior antinuclear antibody-positive uveitis: study protocol for an open-label, adalimumab active-controlled phase 3 clinical trial (JUVE-BRIGHT). Trials. 2021 Oct 9;22(1):689. doi: 10.1186/s13063-021-05651-5.

family: Ramanan

full_name: Athimalaipet V. Ramanan

given: Athimalaipet V.

family: Guly

full_name: Catherine M. Guly

given: Catherine M.

family: Keller

full_name: Stuart Y. Keller

given: Stuart Y.

family: Schlichting

full_name: Douglas E. Schlichting

given: Douglas E.

family: de Bono

full_name: Stephanie de Bono

given: Stephanie

family: Liao

full_name: Ran Liao

given: Ran

family: Quartier

full_name: Pierre Quartier

given: Pierre

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Italy
France
Spain
Germany
United Kingdom

acronym: JUVE-BRIGHT

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Hamburger Zentrum für Kinder und Jugendrheumatologie

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

title: An Open-label, Active-Controlled, Safety, and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

summary: The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.


title: Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.

acronym: DREPSUFINDOL

summary: The analgesic treatment for vaso-occlusive crisis (VOC) in sickle-cell patients is an emergency. The reference treatment is morphine, which requires a venous way sometimes difficult to obtain in these patients. Sufentanil intranasal has been shown to be effective in traumatology. The objective is to evaluate, in VOC, the efficacy of intranasal sufentanil relayed by morphine IV compared to the usual protocol, Equimolar Mixture of Oxygen-Nitrous Oxide (EMONO) relayed by morphine intravenous (IV).

lead_sponsor: University Hospital, Bordeaux

location_country:
French Guiana
France
Guadeloupe

location_facility:
Hôpital Edouard Herriot
Hôpital Louis Mourier
Hôpital Rangueil
Hôpital Charles Nicolle
CHU Pointe à Pitre
CH de Cayenne
Hopital Pellegrin


title: European HIV&STI Prevention Network Study

summary:
The University Hospital Essen is sponsoring the Multicenter human immunodeficiency virus (HIV) and sexually transmitted infections Prevention Network Study (STIPnet) which is funded by Janssen, Pharmaceutical Companies of Johnson & Johnson.

STIPnet study is a prospective observational cohort study aiming to determine the incidence and point prevalence of HIV infection and the most common sexually transmitted infections (STIs) in individuals with sexual risk behavior. In addition, the University Hospital Essen will examine whether individuals at risk for HIV and STI infections would retain in such a study (retention rate) and would be willing to participate in potential HIV and STI prevention trials (willingness to participate).

ipd_sharing_description: The study collaborators recognize the importance of disseminating scientific and medical study data as soon as the study data sets are complete and analysed; therefore, the study leadership would encourage their presentation, discussion and publication at seminars or conferences (national, regional and international) and in reputable scientific journals in open access. All publications resulting from this study will be cleared through the collaborating partners to the study. Anonymous data can be obtained upon request to the PI of the study.Confidentiality of participants will be maintained by the fact that no individual results will be reported or published, only group/aggregate results. Data collected during the trials that underlie the results presented in scientific publications will be shared. Distribution of study data must be always approved by the scientific steering committee of the study and final approval needs to be obtained by the PI.

lead_sponsor: Hendrik Streeck

location_country: Italy France Poland Hungary Spain

location_facility: Center for Prevention and Treatment of Infectious Diseases and Addiction Treatment

location_facility: National Institute for Infectious Diseases L. Spallanzani

location_facility: Centre Hospitalier Universitaire de Bordeaux

intervention_type: Behavioral


lead_sponsor: Universidad Autonoma de Madrid

acronym: ORTHOUNION

location_facility: Arienda Spedali Civili di Brescia II Ortopedia e Traumatologia

location_facility: Department of Orthopaedic Surgery, CHU Nantes

location_facility: Universitätsklinikum Freiburg, Klinik für Orthopädie und Unfallchirurgie

location_facility: Istituto Ortopedico Rizzoli, SSD Fisiopatologia Ortopedica e Medicina Rigenerativa

location_facility: Department of Orthopaedic Trauma, University of Ulm

location_facility: Azienda Universitaria Ospedaliera di Pisa- II, Clinica di Ortopedia e Traumatologia

location_facility: Hospital U. Puerta de Hierro-Majadahonda, Servicio de Cirugía Ortopédica y Traumatología

location_facility: Department of Orthopaedic Surgery, Hospital Henri Mondor

location_facility: Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz

location_facility: Hospital U. La Princesa, Servicio de CirugíaOrtopédica y Traumatología

location_facility: Istituto Ortopedico Galeazzi, Chirugia dell´Anca l

location_facility: Hospital U. Gregorio Marañon, Servicio de Cirugía Ortopédica y Traumatología

location_facility: Universitätsklinikum Frankfurt, Department of Trauma, Hand and Reconstructive Surgery

location_facility: Hospital U. 12 de Octubre, Servicio de Cirugía Ortopédica y Traumatología

location_facility: Department of Orthopaedic Surgery, CHU Tours

location_facility: Azienda Ospedaliero- Universitaria di Modena, Reparto di Ortopedia e Traumatologia

location_facility: Department of Orthopaedic Surgery Toulouse University Hospital

location_facility: Hospital Clínica San Carlos, Servicio de Cirugía Ortopédica y Traumatología

type: Registry Identifier

title: A Multi-centre, Open-label, Randomized, Comparative Clinical Trial of Two Doses of Bone Marrow Autologous MSC+ Biomaterial vs Iliac Crest Autologous Graft, for Bone Healing in Non-union After Long Bone Fractures

summary: ORTHOUNION is a multi-centre, open, comparative, randomized, clinical trial with three parallel arms that aims to compare the efficacy of three treatments to enhance bone healing in patients with long bone non-union.


title: A Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNα-Kinoid (IFN-K) in Adult Subjects With Dermatomyositis

summary: This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα antibodies (immune response) in adult subjects with dermatomyositis

status: Withdrawn

lead_sponsor: Neovacs

location_country: Italy Germany France Switzerland

location_facility: Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus


title: Open-label,Non-randomised,Multicentre,Phase I Study to Assess the Pharmacokinetics, Safety & Tolerability of Osimertinib Following a Single Oral 80mg Dose to Patients w/ Adv Solid Tumours & Normal Renal Function or Severe Renal Impairment.

summary: The purpose of this study is to assess the effect of severe renal impairment on the levels of AZD9291 in the blood in patients with advanced solid tumours compared to patients with normal renal function

ReferenceCitation: Vishwanathan K, Sanchez-Simon I, Keam B, Penel N, de Miguel-Luken M, Weilert D, Mills A, Marotti M, Johnson M, Ravaud A. A multicenter, phase I, pharmacokinetic study of osimertinib in cancer patients with normal renal function or severe renal impairment. Pharmacol Res Perspect. 2020 Aug;8(4):e00613. doi: 10.1002/prp2.613.

name: Clinical Pharmacology and Safety Science R&D, AstraZeneca Boston MA USA

family: Vishwanathan

full_name: Karthick Vishwanathan

given: Karthick

name: Departamento de Oncología Hospital Universitario Virgen del Rocío Seville Spain

family: Sanchez‐Simon

full_name: Inmaculada Sanchez‐Simon

given: Inmaculada

name: Department of Internal Medicine Seoul National University Hospital Seoul South Korea

family: Keam

full_name: Bhumsuk Keam

given: Bhumsuk

name: Department of Medicine Centre Oscar Lambret and Lille University (Univ. Lille) Lille France

family: Penel

full_name: Nicolas Penel

given: Nicolas

name: START Madrid‐Centro Integral Oncológico Clara Campal Sanchinarro University Hospital Madrid Spain

family: Miguel‐Luken

full_name: Maria Miguel‐Luken

given: Maria

family: Weilert

full_name: Doris Weilert

given: Doris

name: Biometrics and Information Sciences AstraZeneca Cambridge UK

family: Mills

full_name: Andrew Mills

given: Andrew

family: Marotti

full_name: Marcelo Marotti

given: Marcelo

name: Clinical Pharmacology and Safety Science R&D, AstraZeneca Cambridge UK

family: Johnson

full_name: Martin Johnson

given: Martin

name: Medical Oncology Department Bordeaux University HospitalSaint‐André Hospital Bordeaux France

family: Ravaud

full_name: Alain Ravaud

given: Alain

currency_apc_doaj: USD

journal_name: Pharmacology Research & Perspectives

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: AstraZeneca

location_country:
Korea, Republic of
France
Spain


title: A Phase II, Open-label, Randomized-controlled Trial Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody Atezolizumab for the Treatment in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

acronym: ImmunoCobiVem

summary:
Most patients with locally advanced or metastatic tumors succumb to their disease. Thus, there is a substantial need for novel therapeutic strategies to improve the outcome for patients with advanced or metastatic melanoma. Targeting the the Ras/Raf signalling pathway by BRAF and MEK inhibition as well as targeting immunologic checkpoint control with an antiPD-L1 antibody have emerged as treatment option.

In this study the best timing for sequential use of both treatment options (BRAF/MEK inhibition and antiPD-L1 antibody) in patients with unresectable or metastatic BRAFV600 mutant melanoma will be assessed.

lead_sponsor: University Hospital, Essen

location_country: Germany Serbia France Greece

location_facility: National Centre for Tumour Diseases (NCT)

location_facility: University Hospital Essen, Department of Dermatology, Skin Cancer Center

location_facility: Gesellschaft für Klinische Forschung Ludwigshafen mbH

location_facility: University Hospital Mannheim, Clinic for Dermatology


title: An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial

acronym: RIALTO

summary: To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.

location_country:
Italy
Thailand
France
Poland
Korea, Republic of


ReferenceCitation: Burmester GR, Buttgereit F, Bernasconi C, Álvaro-Gracia JM, Castro N, Dougados M, Gabay C, van Laar JM, Nebesky JM, Pethoe-Schramm A, Salvarani C, Donath MY, John MR; SEMIRA collaborators. Continuing versus tapering glucocorticoids after achievement of low disease activity or remission in rheumatoid arthritis (SEMIRA): a double-blind, multicentre, randomised controlled trial. Lancet. 2020 Jul 25;396(10246):267-276. doi: 10.1016/S0140-6736(20)30636-X.

family: Burmester

full_name: Gerd R Burmester

given: Gerd R

family: Buttgereit

full_name: Frank Buttgereit

given: Frank

family: Bernasconi

full_name: Corrado Bernasconi

given: Corrado

family: Álvaro-Gracia

full_name: Jose M Álvaro-Gracia

given: Jose M

family: Castro

full_name: Nidia Castro

given: Nidia

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: Gabay

full_name: Cem Gabay

given: Cem

family: van Laar

full_name: Jacob M van Laar

given: Jacob M

family: Nebesky

full_name: Jan Michael Nebesky

given: Jan Michael

family: Pethoe-Schramm

full_name: Attila Pethoe-Schramm

given: Attila

family: Salvarani

full_name: Carlo Salvarani

given: Carlo

family: Donath

full_name: Marc Y Donath

given: Marc Y

family: John

full_name: Markus R John

given: Markus R

family: Constantin

full_name: Arnaud Constantin

given: Arnaud

family: Gottenberg

full_name: Jacques Eric Gottenberg

given: Jacques Eric

family: Loiseau-Peres

full_name: Sylvie Loiseau-Peres

given: Sylvie

family: Nguyen

full_name: Minh Nguyen

given: Minh

family: Schaeverbeke

full_name: Thierry Schaeverbeke

given: Thierry

family: Alten

full_name: Rieke H.-E. Alten

given: Rieke H.-E.

family: Amberger

full_name: Christopher Amberger

given: Christopher

family: Biewer

full_name: Werner A. Biewer

given: Werner A.

family: Boche

full_name: Konrad Boche

given: Konrad

full_name: Gerd Ruediger Burmester

given: Gerd Ruediger

family: Engel

full_name: Andreas Engel

given: Andreas

family: Feuchtenberger

full_name: Martin Feuchtenberger

location_country:
Italy
Serbia
France
Tunisia
Russian Federation
Germany

location_facility: Rheumatologische Facharztpraxis Maren Sieburg

location_facility: Special hospital for rheumatic diseases Novi Sad

location_facility: SchlossPark-Klinik Berlin; Int. Med. II, Rheum. Osteo

location_facility: Rheumatologische Schwerpunktpraxis am Feuersee

location_facility: Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie

location_facility: SMO.MD GmbH, Zentrum für klinische Studien

location_facility: Irccs Policlinico San Matteo; Reumatologia Adulti

location_facility: Institute of Rheumatology and Cardiovascular Diseases; Rheumatology

location_facility: Arcispedale Santa Maria Nuova; Reumatologia

location_facility: Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia

location_facility: Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV

location_facility: Republican clinical hospital named after G.G. Kuvatov

location_facility: SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF

location_facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Rheumatologie/Immunologie

location_facility: Rheumatologisches MVZ Dresden GmbH, Dres. Holger Schwenke, Reiner Schwenke, Annekatrin Georgi

location_facility: Dres. Florian Schuch, Ruediger de la Camp, Martin Hammerschmidt u.w.

location_facility: Rheumazentrum Ratingen - Studienambulanz

location_facility: Military Medical Academy; Clinic of Rheumatology

location_facility: Rheumatologische Gemeinschaftspraxis Grafschaft, Dr. med. Dorothea Pick, Dr. med. Christopher Amberg

location_facility: Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Med.Klinik III

location_facility: Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie

location_facility: Hopital Farhat Hached; Service Rhumatologie

location_facility: FSBI Scientific Research Institute of Clinical and Experimental Lymphology of SB of RAMS

location_facility: Klinik der Uni zu Köln; Klinik für Innere Medizin

title: Prospective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Patients

summary: This Phase IIIb/IV, two-arm, randomized, double-blind, placebo-controlled, parallel-group, international, multicenter trial compares the change in disease activity (as assessed by Disease Activity Score in 28 joints [DAS28] erythrocyte sedimentation rate [ESR]) from randomization to Week 24 post-randomization, in participants with stable low disease activity [LDA] (DAS28 ESR score less than or equal to [<=] 3.2) who receive tocilizumab, and have been randomized to either continue or taper prednisone in a double-blinded fashion.


title: A Prospective, Multicenter, Randomized, Comparative Clinical Study to Compare the Safety and Effectiveness of Two Vertebral Compression Fracture (VCF) Reduction Techniques: the SpineJack® and the KyphX Xpander® Inflatable Bone Tamp

acronym: SAKOS

summary: The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.

lead_sponsor: Vexim SA

location_country: Italy Switzerland France Spain Germany

location_facility: Hôpital Jean Minjoz Service Neurochirurgie

location_facility: CHU Hôtel Dieu Service Neuro traumatologie

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Clinico Universitario de Valladolid,

location_facility: Klinik und Poliklinik fur Orthopädie Universitatsklinikum

location_facility: Krankenhaus NEUWERK Sankt Augustinus kliniken


title: Phase II Biomarker Study Evaluating The Upfront Combination Of BRAF Inhibitor Dabrafenib With MEK Inhibitor Trametinib Versus The Combination After Eight Weeks Of Monotherapy With Dabrafenib Or Trametinib In Patients With Metastatic And Unresectable Stage III Or IV Melanoma Harbouring An Activating BRAF Mutation

summary: This is a three-arm, open-label, randomised Phase II study to evaluate whether the different sequencing of dabrafenib and trametinib monotherapies and the upfront combination has an impact on translational or clinical activity in subjects with BRAF mutant metastatic unresectable stage IIIc or IV melanoma. Both dabrafenib and trametinib have demonstrated clinical activity as monotherapies and in combination in BRAF-mutant melanoma. However, duration of responses seem to be limited due to acquired drug resistance. The goal of this protocol is to study the sequential effects of BRAF and MEK inhibition on skin, blood and tumour biomarkers and to study the correlation between biomarkers and response to treatment and intrapatient toxicity. Approximately 54 eligible subjects will be randomised in the ratio of 1:1:1 to one of the three treatment arms.

primary_purpose: Diagnostic


title: A Phase I/II Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70.

summary: The purpose of this study is to determine the optimal dose of ARGX-110 in participants with advanced malignancies and to assess efficacy of ARGX-110 (exploratory efficacy cohort 5 only).

ReferenceCitation: Silence K, Dreier T, Moshir M, Ulrichts P, Gabriels SM, Saunders M, Wajant H, Brouckaert P, Huyghe L, Van Hauwermeiren T, Thibault A, De Haard HJ. ARGX-110, a highly potent antibody targeting CD70, eliminates tumors via both enhanced ADCC and immune checkpoint blockade. MAbs. 2014 Mar-Apr;6(2):523-32. doi: 10.4161/mabs.27398. Epub 2013 Dec 6.

family: Silence

full_name: Karen Silence

given: Karen

family: Dreier

full_name: Torsten Dreier

given: Torsten

family: Moshir

full_name: Mahan Moshir

given: Mahan

family: Ulrichts

full_name: Peter Ulrichts

given: Peter

family: Gabriels

full_name: Sofie ME Gabriels

given: Sofie ME

family: Saunders

full_name: Michael Saunders

given: Michael

family: Wajant

full_name: Harald Wajant

given: Harald

family: Brouckaert

full_name: Peter Brouckaert

family: Huyghe

full_name: Leander Huyghe

given: Leander

family: Van Hauwermeiren

full_name: Tim Van Hauwermeiren

given: Tim

family: Thibault

full_name: Alain Thibault

given: Alain

family: De Haard

full_name: Hans J De Haard

given: Hans J

journal_name: mAbs

publisher: Informa UK Limited

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country: Belgium France


title: An Open-Label, Single-Arm Phase III Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Subjects

acronym: RESTORE

summary: The purpose of this study to evaluate the efficacy, safety and tolerability of TMC435 in combination with Peginterferon alfa-2a (PegINF alfa-2a) and ribavirin (RBV) in both treatment-naïve and treatment experienced, chronic hepatitis C (HCV) virus, genotype-4 infected patients.

ReferenceCitation: Moreno C, Hezode C, Marcellin P, Bourgeois S, Francque S, Samuel D, Zoulim F, Grange JD, Shukla U, Lenz O, Ouwerkerk-Mahadevan S, Fevery B, Peeters M, Beumont M, Jessner W. Efficacy and safety of simeprevir with PegIFN/ribavirin in naïve or experienced patients infected with chronic HCV genotype 4. J Hepatol. 2015 May;62(5):1047-55. doi: 10.1016/j.jhep.2014.12.031. Epub 2015 Jan 14.

family: Moreno

full_name: Christophe Moreno

given: Christophe

family: Hezode

full_name: Christophe Hezode

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

family: Bourgeois

full_name: Stefan Bourgeois

given: Stefan

family: Francque

full_name: Sven Francque

given: Sven

family: Samuel

full_name: Didier Samuel

given: Didier

family: Zoulim

full_name: Fabien Zoulim

given: Fabien

family: Grange

full_name: Jean-Didier Grange

given: Jean-Didier

family: Shukla

full_name: Umesh Shukla

given: Umesh

family: Lenz

full_name: Oliver Lenz

given: Oliver

family: Ouwerkerk-Mahadevan

full_name: Sivi Ouwerkerk-Mahadevan

given: Sivi

family: Fevery

full_name: Bart Fevery

given: Bart

family: Peeters

full_name: Monika Peeters

given: Monika

family: Beumont

full_name: Maria Beumont

given: Maria

family: Jessner

full_name: Wolfgang Jessner

given: Wolfgang

journal_name: Journal of Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Janssen R&D Ireland


title: An Open-Label, Single-Arm, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Sensitized Recipients of a Kidney Transplant From a Deceased Donor.

summary:
Primary Objective:

To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Italy
Sweden
France
Australia
Spain
United Kingdom


ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Italy
France
Czechia
Poland
Belgium
Germany
United Kingdom

location_facility:
Site FR31
Site FR35
Site FR34
Site GB62
Site PL51
Site FR32
Site IT74
Site GB64
Site CZ42
Site FR33
Site GB61
Site BE21
Site BE22
Site PL52
Site DE41
Site IT75

title: A Phase II, Open-Label, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From a Prograf® Based Immunosuppressive Regimen to a Tacrolimus Prolonged Release, Advagraf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up

summary:
Parts A & B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.

Part C: Continuation of long-term follow-up and provision of ongoing study medication to subjects to whom Advagraf® is currently not available.