title: A Phase 3 Study of PTC923 in Subjects With Phenylketonuria

summary: The main purpose of this trial is to evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in participants with phenylketonuria as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (that is, the average of each respective treatment dose 2-week period of double-blind treatment).

lead_sponsor: PTC Therapeutics

location_country:
Germany
Italy
Portugal
United Kingdom
Denmark
Australia
Brazil
Netherlands
Mexico
United States
Spain
Turkey
Canada
Georgia
France

location_facility: CHRU de Tours- Hôpital Pédiatrique de Clocheville

location_facility: University of Utah, Division of Medical Genetics (pediatric and adult clinic)

location_facility: Centro Hospitalar Universitário Do Porto, Epe

location_facility: University of Colorado and the Children's Hospital CO

location_facility: Copenhagen University Hospital, Rigshospitalet

location_facility: CENTRO HOSPITALAR UNIVERSITÁRIO LISBOA NORTE Hospital de Santa Maria,

location_facility: University of Texas Health Science Center of Texas

location_facility: Division of Inherited Metabolic Diseases, Azienda Ospedaliera-Università Padova

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Stanford University Center for Academic Medicine

location_facility: Metabolics and Genetics in Calgary (MAGIC) Clinic, Ltd.

location_facility: İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi

location_facility: Ege University Faculty of Medicine Children Hospital

location_facility: Cukurova Üniversity Balcali Hospital Health Application and Research Center

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

location_facility: University Children's Hospital Hamburg Eppendorf (Kinder-UKE) Klinik für Kinder- und Jugendmedizin (Kinder-UKE)

location_facility: Universitätsklinikum Heidelberg / Zentrum für Kinder- und Jugendmedizin / Sektion für Neuropädiatrie & Stoffwechselmedizin

location_facility: UF College of Medicine, Department of Pediatrics Division of Genetics and Metabolism

location_facility: Icahn School of Medicine at Mount Sinai (ISMMS)

location_facility: The Hospital for Sick Children University of Toronto, Adult Clinic: The Fred A Litwin Family Centre in Genetic Medicine University Health Network & Mt. Sinai Hospital


title: A Phase IB Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

summary: This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first two cycles of mosunetuzumab. An additional arm has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) inhibitor.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
United Kingdom
Australia
United States
Spain
France

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

location_facility: Osp. San Raffaele; Dip. Di Oncoematologia

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: CHU DE CLERMONT FERRAND; Service de Thérapie Cellulaire et d'Hématologie clinique adultes

location_facility: Universitätsklinikum Augsburg; II. Med. Klinik

location_facility: Uniklinik Koln; Klinik I fur Innere Medizin

location_facility: Uni of Texas - Md Anderson Cancer Center; Dept of Leukemia

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Churchill Hospital; Department of Oncology

location_facility: Memorial Sloan-Kettering Cancer Center; Hematology/Oncology

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

acronym: Progress

summary: This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).

design_allocation: Randomized

ipd_sharing_description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

lead_sponsor: Incyte Corporation

location_country:
Germany
New Zealand
Argentina
Australia
Brazil
Turkey
Chile
Canada
France
Portugal
United States
China
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Russian Federation

location_facility: Amsterdam Umc - Vu Medisch Centrum (Vumc)

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: Royal Manchester Childrens Hospital - Department of Paediatric Endocrinology

location_facility: Centro Hospitalar Universitario de Lisboa Norte, Hospital Santa Maria

location_facility: University Health Network Toronto General Hospital

location_facility: Penn Medicine - Perelman Center For Advanced Medicine

location_facility: University of California San Francisco Medical Center

location_facility: Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Beijing Childrens Hospital Capital Medical University

location_facility: Nasonova Research Institute of Rheumatology

location_facility: Groote Schuur Hospital Radiation Oncology


title: A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Familial Chylomicronemia Syndrome

acronym: PALISADE

summary: The purpose or AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of ARO-APOC3 or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive ARO-APOC3.

status: Active, not recruiting

lead_sponsor: Arrowhead Pharmaceuticals

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Japan
Turkey
Croatia
Canada
Serbia
France
United States
Belgium
Oman
Singapore
Austria
Mexico
Korea, Republic of
Spain
Israel

location_facility: Centre Hospitalier Universitaire (CHU) de Liege

location_facility: Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves

location_facility: Institute de Recherches Cliniques de Montreal

location_facility: National Institute of Medical Sciences and Nutrition - Salvador Zubiran (INCMNSZ)

location_facility: Ascension St. Vincent Cardiovascular Research Institute

location_facility: Clinical Center of Serbia, Institute of Endocrinology, Diabetes and Metabolic Diseases

location_facility: Hospital Clinico Universitario de Santiago

location_facility: New York University Langone Medical Center

location_facility: Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research

location_facility: University Hospital Center Zagreb -Rebro, Department for Metabolic Diseases

location_facility: Instituto de Diabetes Obesidad y Nutrición S.C.

location_facility: Clinique des Maladies Lipidiques de Quebec Inc.

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Ege University Hospital Department Of Infectious Diseases

location_facility: Centro Especializado en Diabetes Obesidad y Prevención de entermedades Cardiovasculares (CEDOPEC)


acronym: CROSSWALK-c

summary: This study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of VOEs in participants with SCD.

location_facility: Mississippi Center for Advanced Medicine

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Hôpital Saint Eloi; Service de Médecine interne

location_facility: Mustafa Kemal University Medical Faculty; Infection

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Hospital das Clínicas Faculdades Médicas de Ribeirão Preto

location_facility: Children's Hospital of Michigan; Pediatrics

location_facility: CHU Henri Mondor; Service de médecine interne

location_facility: Adana Acibadem Hospital; Pediatric Hematology

location_facility: Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Medicina Interna

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi

location_facility: East Carolina University; Brody School of Medicine

location_facility: Università degli Studi della Campania Luigi Vanvitelli; UOC Ematologia ed oncologia pediatrica

title: A Randomized Double-Blind Phase IIA Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)

type: EudraCT Number

source: euctr

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical -trials/data-sharing/).

location_country:
Italy
United Kingdom
Brazil
Netherlands
United States
Spain
South Africa
Turkey
France


title: An Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

summary: The purpose of this study is to evaluate the safety and tolerability of extended dosing with Eplontersen in participants with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN).

ipd_sharing: No

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Italy
Cyprus
Portugal
New Zealand
Argentina
Australia
Brazil
Sweden
United States
Spain
Turkey
Taiwan
Canada
France

location_facility: Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria

location_facility: University of North Carolina Hospitals - Neurology Clinic

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Carlo Besta

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Hospital Universitario Clementino Fraga Filho

location_facility: Centro Hospitalar Universitário do Porto - Hospital Geral de Santo Antonio

location_facility: Perron Institute for Neurological and Translational Science

location_facility: Johns Hopkins University Neurology Research Office

location_facility: Istanbul Üniversitesi - Istanbul Tip Fakültesi

location_facility: The Cyprus Institute of Neurology and Genetics

location_facility: Indiana University Health University Hospital


title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of 3 Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II

summary: A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.

status: Terminated

study_completion_date_type: Actual

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: KalVista Pharmaceuticals, Ltd.

location_country:
Germany
Italy
North Macedonia
New Zealand
Hungary
United Kingdom
Australia
United States
Czechia
Bulgaria
Canada
Puerto Rico
France

status_simplified: Unknown


title: A Phase 2, Open-Label, Multicenter Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

summary: The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC

lead_sponsor: Revolution Medicines, Inc.

collaborators: Sanofi Amgen

sponsor_collaborators:
Revolution Medicines, Inc.
Sanofi
Amgen

location_country:
Germany
Italy
United Kingdom
Australia
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Hospital Larrey Universite Paul Sabatier

location_facility: CHRISTUS St. Michael-Colom and Carney Clinic P.A

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: APHM Hopital Nord, Service d'Oncologie Multidisciplinaire et innovations therapeutics

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Comprehensive Cancer Center Mainfranken, University Wuerzburg

location_facility: American Oncology Partners of Maryland, PA

location_facility: Charite Benjamin Franklin Comprehensive Cancer center

location_facility: Kaohsiung Medical University Chung Ho Memorial Hospital

location_facility: Lung Cancer Center, University of Saarland


title: A Phase 2 Study to Assess the Efficacy and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva in Male and Female Paediatric and Adult Participants.

acronym: FALKON

summary:
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO). It is often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to abnormal stiffening and immobility (ankyloses) of major joints with cumulative and irreversible loss of movement and disability.

This study will evaluate the efficacy of 2 dosing regimens of IPN60130 in inhibiting new HO volume compared with placebo (a dummy treatment) in adult and paediatric participants with FOP. It will be assessed by a scan (provides internal images of the body) called low dose Whole Body Computed Tomography (WBCT), excluding head.

Adults and participants 5 years of age or older are also eligible for a sub study to evaluate HO lesions assessed by another type of scan, Fluorine-18-labelled natrium fluoride Positron Emission Tomography-Computed Tomography ([18F]NaF PET-CT ).

ipd_sharing_description: Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.

lead_sponsor: Clementia Pharmaceuticals Inc.

sponsor_collaborators:
Clementia Pharmaceuticals Inc.
Ipsen

location_country:
Italy
Colombia
Portugal
United Kingdom
Argentina
Australia
Brazil
Japan
Mexico
Belgium
Netherlands
United States
China
Korea, Republic of
Spain
Sweden
Canada
France

location_facility: University of Alberta, Alberta Health Services (AHS)

location_facility: Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust

location_facility: University of California San Francisco (UCSF)

location_facility: The Perelman School of Medicine - The University of Pennsylvania

location_facility: Aichi Children's Health and Medical Center

location_facility: Fundacion Cardioinfantil - Instituto De Cardiologia

location_facility: Hospital Universitario Y Politecnico La Femerge

location_facility: Hospital Regional de Alta Especialidad del Bajio

location_facility: University Health Network (UHN), Toronto General Hospital (TGH)

location_facility: Children's Hospital Capital Institute of Pediatrics (CIP)

location_facility: Hospital Center Lisbon North, E.P.E- Hospital Santa Maria

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Ortopedico Rizzoli (Rizzoli Orthopedic Institute)

location_facility: Royal North Shore Hospital - New South Wales

location_facility: Groupe Hospitalier Necker Enfants Malades


title: An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT-EXT)

acronym: ASSERT-EXT

summary: An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT)

lead_sponsor: Albireo

location_country:
Germany
Italy
Poland
United Kingdom
Netherlands
Belgium
United States
Malaysia
Turkey
France

location_facility: Universitatsklinik fur Kinder-und Jugendmedizin Tubingen

location_facility: Istanbul University Istanbul Medical Faculty Hospital

location_facility: The Childrens Hospital at Montefiore Albert Einstein School of Medicine

location_facility: Cliniques Universitaires Saint-Luc Bruxelles

location_facility: Antenne pediatrique du CIC-Hopital Jeanne De Flandre

location_facility: Hassenfeld Children's Hospital at NYU Langone


title: A Phase 3b, Randomized, Double-blind, Placebo-controlled, 24-week Study to Assess the Efficacy and Safety of Fezolinetant in Menopausal Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) and Considered Unsuitable for Hormone Replacement Therapy

acronym: Daylight

summary:
This study is for women in menopause who have moderate to severe hot flashes. It is for women who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life.

The study medicines (also called investigational products, or IP) are tablets of fezolinetant or placebo. An investigational product means that the product is not yet licensed. In this study, a placebo is a dummy treatment that looks like fezolinetant but does not have any medicine in it. The study will compare fezolinetant with the placebo to learn if fezolinetant reduces the number and severity of hot flashes.

Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. Women will be picked for 1 of 2 treatments (fezolinetant or placebo) by chance alone.

Women who take part in the study will take 2 tablets every day for 24 weeks. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study medicines (fezolinetant or placebo). The women will continue recording information about their hot flashes on the electronic device or their phone. They will also use another device to answer questions about how hot flashes affect their daily life.

During the study, the women will visit their study clinic several times for a check-up. This will happen during Weeks 2, 4, 8, 12, 16, 20, 24, and 27. Some women may be able to have home visits instead, from Week 2 to Week 20. At the check-up, they will be asked if they have any medical problems. Other checks will include vital signs (heart rate, temperature and blood pressure) and some blood samples taken for laboratory tests. At some check-ups, the women will have a physical exam. In Week 2 and Week 24, the women will have an ECG to check their heart rhythm. Women who have a uterus will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs.

The last check-up (at Week 27) will be 3 weeks after they take their last tablets of study medicine (fezolinetant or placebo).

status: Completed

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 Global Development, Inc.

location_country:
Finland
Germany
Italy
Poland
Hungary
Norway
Denmark
United Kingdom
Sweden
Netherlands
Belgium
Spain
Turkey
Czechia
Canada
France

location_facility:
Site FR33001
Site CA15009
Site PL48004
Site DK45004
Site DK45003
Site TR90008
Site CZ42005
Site FI35801
Site PL48006
Site GB44007
Site ES34003
Site CA15002
Site DK45005
Site CZ42008
Site PL48007
Site PL48012
Site CZ42009
Site CA15014
Site ES34002
Site CA15005
Site FI35803
Site CZ42007
Site DE49002
Site DE49008
Site SE46003
Site CA15008
Site HU36002
Site GB44006
Site CZ42004
Site CA15012
Site CZ42010
Site DK45002
Site DE49004
Site HU36004
Site PL48003
Site HU36001
Site CA15001
Site NL31004
Site PL48001
Site CA15007
Site CZ42011
Site TR90001
Site CA15003
Site CZ42002
Site DE49006
Site NO47001
Site NL31001
Site GB44003
Site PL48013
Site PL48017
Site PL48010
Site ES34001
Site IT39006
Site DE49005
Site CA15010
Site ES34005
Site CA15011
Site PL48009
Site SE46004
Site SE46002
Site GB44004
Site CZ42006
Site TR90002
Site FR33003
Site PL48011
Site BE32005
Site GB44002
Site IT39002
Site CZ42003

status_simplified: Completed


title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington's Disease (SELECT-HD)

summary: This is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and PD of WVE-003 in adult patients with early-manifest HD who carry the targeted single nucleotide polymorphism (SNP) - SNP3.

lead_sponsor: Wave Life Sciences Ltd.

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Australia
Netherlands
Spain
Canada
France

location_facility: Royal Hospital for Children, Pharmacy Aseptic Unit

location_facility: Institut du Cerveau et de la Moelle Epiniere

location_facility: Cardiff University, Schools of Medicine and Biosciences

location_facility: Centre Hospitalier de l-Universite de Montreal

location_facility: Royal Devon and Exeter Hospital NHS Trust


title: A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy

acronym: MINORE

summary: This study will evaluate the potential placental transfer of ocrelizumab in women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (B cell levels) in the infant.

primary_purpose: Other

sponsor_collaborators:
Hoffmann-La Roche
PPD
Laboratory Corporation of America
Illingworth Research Group

location_country:
Germany
United Kingdom
Switzerland
United States
Spain
France

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Hospital of the University of Pennsylvania

location_facility: Hopital Pierre Wertheimer - Hopital Neurologique

location_facility: MultipEL Studies - Institut für klinische Studien


title: A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

summary: This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

lead_sponsor: Cogent Biosciences, Inc.

location_country:
Germany
Italy
Norway
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Canada
France

location_facility: University College London Hospital - NHS Foundation Trust

location_facility: Winship Cancer Institute - Emory University

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse

location_facility: University of Alabama at Birmingham (UAB) Hospital

location_facility: St. Michael's Hospital - Unity Health Toronto

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Columbia University Irving Medical Center

location_facility: IRCCS Azienda Ospedaliero Universitaria di Bologna

location_facility: Centre Hospitalier Universitaire (CHU) de Poitiers

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals

location_facility: Huntsman Cancer Institute - University of Utah Health

location_facility: City of Hope Comprehensive Cancer Center


title: Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

summary: This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.

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.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
United Kingdom
Singapore
Denmark
Australia
Brazil
Japan
Netherlands
Belgium
United States
China
Korea, Republic of
Spain
Malaysia
Thailand
Taiwan
Moldova, Republic of
Georgia
France


title: A Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

summary: The main purpose of this study is to evaluate the safety, recommended dose, and preliminary anti-tumor activity of WU-CART-007 in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL).

lead_sponsor: Wugen, Inc.

location_country:
United States
Australia
Netherlands
France

location_facility:
University of Wisconsin
Prinses Maxima Centrum
Hospital Saint- Louis
Moffit Cancer Center
City of Hope
Vanderbilt University
Erasmus MC
Children's Hospital Los Angeles
University Hospital Robert Debre
Peter MacCallum Cancer Centre
Washington University
Children's Hospital of Philadelphia

intervention_type: Biological


title: A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma

summary: This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in individuals with circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment.

location_country:
Poland
Denmark
Netherlands
United States
Spain
France

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Hematología

location_facility: University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Hospital Clinic i Provincial de Barcelona; Hematology

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku

location_facility: Aarhus Universitetshospital Skejby; Blodsygdomme

location_facility: Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli

location_facility: Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Stanford Cancer Institute Inpatient Investigational Pharmacy; Pharmacy

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

location_facility: Memorial Sloan Kettering Cancer Center at Nassau


title: A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors

summary: This Phase 1, multicenter, open-label, dose escalation and expansion study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-609 given intravenously in subjects with advanced synovial sarcoma or advanced SMARCB1-loss tumors.

lead_sponsor: Foghorn Therapeutics Inc.

location_country:
United States
Italy
Spain
France

location_facility:
Massachusetts General Hospital
Hospital Universitari Vall d'Hebron
Dana-Farber Cancer Institute
MD Anderson Cancer Center
University of Miami Health System
City of Hope
Centre Leon Berard
Istituto Nazionale dei Tumori
Institut Gustave Roussy
Fred Hutchinson Cancer Research Center
Sarah Cannon Research Institute
Memorial Sloan Kettering Cancer Center


title: A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Sustained Virologic Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Received and Responded to GSK3228836 in a Previous Treatment Study

summary: This is a long-term follow-up study to assess durability of efficacy, as measured by SVR, in participants who have received prior treatment with GSK3228836 and achieved a complete or partial response. No further treatment with GSK3228836 will be administered in this study.

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

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Argentina
Japan
Thailand
Canada
France
Hong Kong
United States
Romania
China
Malaysia
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation


acronym: Phase 2a Study of Efinopegdutide (MK-6024) in Individuals With NAFLD

lead_sponsor: Merck Sharp & Dohme LLC

summary: The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.

ReferenceType: result

ReferenceCitation: Romero-Gomez M, Lawitz E, Shankar RR, Chaudhri E, Liu J, Lam RLH, Kaufman KD, Engel SS; MK-6024 P001 Study Group. A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease. J Hepatol. 2023 Oct;79(4):888-897. doi: 10.1016/j.jhep.2023.05.013. Epub 2023 Jun 22.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

location_facility: Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 1302)

location_facility: Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 0908)

location_facility: Sheba Medical Center-The Liver Diseases Center ( Site 0700)

location_facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (

location_facility: National Taiwan University Hospital ( Site 1501)

location_facility: Azienda Ospedaliero Universitaria ( Site 0803)

location_facility: Dokuz Eylül Üniversitesi-Endocrinology and Met. ( Site 1610)

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital F-ENDOCRINOLOGY-DIABETOLOGY ( Site 0401)

location_facility: Severance Hospital, Yonsei University Health System ( Site 1305)

location_facility: Korea University Guro Hospital ( Site 1300)

location_facility: New Technologies of Medicine Clinic ( Site 1204)

location_facility: American Research Corporation at Texas Liver Institute ( Site 1920)

location_facility: Hacettepe Universitesi-internal diseases ( Site 1602)

location_facility: Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 1606)

location_facility: Chang Gung Medical Foundation-Linkou Branch-Division of hepatology, department of gastroenterology (

location_facility: Inha University Hospital-Gastroenterolgy/Hepatology ( Site 1303)

location_facility: Texas Clinical Research Institute ( Site 1910)

location_facility: NATIONAL CHENG-KUNG UNI. HOSP.-Liver Research team of National Cheng Kung University Hospital ( Site

location_facility: Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 0201)

location_facility: Arké Estudios Clínicos S.A. de C.V.-Gastroenterology-Hepatology ( Site 0906)

location_facility: Saint Petersburg City Polyclinic 117-endocrinology department ( Site 1201)

location_facility: Sweet Hope Research Specialty, Inc ( Site 1902)

location_facility: Rambam Health Care Campus-Liver disease unit ( Site 0704)

location_facility: Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 1405)

location_facility: Soon Chun Hyang University Bucheon Hospital ( Site 1304)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0101)

location_facility: HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 1402)

location_facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0105)

location_facility: centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0402)

location_facility: Centro de Investigación y Gastroenterología ( Site 0902)

location_facility: L.T. Mala National Institute of Therapy of NAMS of Ukraine-Department of Aging Studies and Prevent

location_facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 1404)

location_facility: Clinical Trials of Texas, Inc. ( Site 1906)

location_facility: Christchurch Hospital-Gastroenterology Research ( Site 1002)

location_facility: Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council-Therapy department (

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Medicine ( Site 0804)

location_facility: IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0107)

location_facility: Nasz Lekarz Przychodnie Medyczne ( Site 1105)

location_facility: Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho ( Site 1710)

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0805)

location_facility: Auckland City Hospital-Liver Research Unit ( Site 1003)

location_facility: Adonis Plus-Outpatient department ( Site 1701)

location_facility: Westmead Hospital-Gastroenterology & Hepatology ( Site 0204)

location_facility: Avix Investigación Clinica, S.C. ( Site 0907)

location_facility: Gazi Universitesi-gastroenterology ( Site 1605)

location_facility: CHUS - Hospital Clinico Universitario ( Site 1403)

location_facility: Baylor College of Medicine-Advanced Liver Therapies ( Site 1960)

location_facility: Catalina Research Institute, LLC ( Site 1939)

location_facility: Ukrainian Research Institute of Therapy ( Site 1704)

location_facility: Shaare Zedek Medical Center-Liver Unit ( Site 0703)

location_facility: Centrum Medyczne Pratia Warszawa ( Site 1107)

location_facility: Sourasky Medical Center-Gastroenterology and Liver Disease ( Site 0702)

location_facility: Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1400)

location_facility: Ankara University Department of Hematology, Clinical Research Unit ( Site 1603)

location_facility: Floridian Clinical Research, LLC ( Site 1950)

location_facility: Humanitas-Medicina interna ed Epatologia ( Site 0800)

location_facility: Istanbul University Capa Campus-Gastroenterology ( Site 1604)

location_facility: Heritage Medical Research Clinic ( Site 0302)

title: A Phase 2a, Randomized, Active-Comparator-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Individuals With Nonalcoholic Fatty Liver Disease

type: Other Identifier

location_country:
Italy
Poland
New Zealand
Israel
Argentina
Australia
Mexico
United States
Korea, Republic of
Spain
Turkey
Taiwan
Canada
Ukraine
Russian Federation
France


title: A Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Malignancies

summary: This a A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB003 in Subjects with Advanced Malignancies

lead_sponsor: Ningbo Newbay Technology Development Co., Ltd

location_country:
United Kingdom
United States
China
Korea, Republic of
Spain
France

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: The Affiliated Drum Tower Hospital of Nanjing University

location_facility: The First Affiliated Hospital of Sun Yat-sen University

location_facility: The 2nd Hospital of Xi'An Jiaotong University

location_facility: Oregon Health & Science University (OHSU)

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: Xiangya Hospital, Central South University

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: The First Affiliated Hospital of Zhejiang University school of medicine

location_facility: The Second Hospital of Anhui Medical University

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: U T MD Anderson Cancer Center Investigational Pharmacy Services

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch


type: Registry Identifier

title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises

summary: This Phase 3 study will assess the safety and efficacy of a single dose of inclacumab, a P-selectin inhibitor, for a vaso-occlusive crisis (VOC) after an index VOC in participants with sickle cell disease (SCD). Participants will be randomized to receive either inclacumab or placebo.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Germany
Italy
Colombia
United Kingdom
Nigeria
Brazil
Lebanon
United States
Saudi Arabia
Turkey
Zambia
Oman
Kenya
France

location_facility: Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Alliance for Childhood Diseases dba Cure 4 The Kids Foundation

location_facility: S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro

location_facility: Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO

location_facility: Kenya medical Research Institute-centre for Respiratory Disease Research

location_facility: Universitatsklinikum Regensburg Padiatrische Hamatologie, Onkologie und Stammzelltransplantation

location_facility: UO di Farmacia Clinica, Dipartimento di Medicina Sperimentale Azienda Ospedaliera Universitaria

location_facility: Organizacion Clinica Bonnadona Prevenir S.A.S.

location_facility: UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"

location_facility: DUMC Investigational Drug Services Pharmacy

location_facility: American University of Beirut Medical Center

location_facility: University Teaching Hospital- Children's Hospital

location_facility: University of South Alabama Children's and Women's Hospital

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo -HCFMUSP

location_facility: DAI Materno-Infantile, UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi Vanvitell

location_facility: UCSF Benioff Children's Hospital, Oakland

location_facility: Barau Dikko Teaching Hospital/Kaduna State University

location_facility: Kemri/Crdr, Siaya, Kemri Clinical Research Annex,

location_facility: Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi

location_facility: Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES)

location_facility: Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: University of Michigan Hospitals - Michigan Medicine

location_facility: UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"

location_facility: Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital

location_facility: Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji

location_facility: Ahmadu Bello University Teaching Hospital (ABUTH)


acronym: CROSSWALK-a

lead_sponsor: Hoffmann-La Roche

summary: The purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a VOE) that requires hospitalisation in adult and adolescent participants with SCD. The primary objective of this study is safety and will additionally evaluate pharmacokinetics (how crovalimab is processed by your body), pharmacodynamics (how your body reacts to crovalimab) and the preliminary efficacy of crovalimab compared with placebo.

location_facility: Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Medicina Interna

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Children's Hospital of Michigan; Pediatrics

location_facility: Hôpital Saint Eloi; Service de Médecine interne

location_facility: CHU Henri Mondor; Service de médecine interne

location_facility: East Carolina University; Brody School of Medicine

title: A Phase IB Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Patients With Sickle Cell Disease (SCD)

location_country:
Italy
United Kingdom
Brazil
Netherlands
United States
Spain
South Africa
France


title: A Phase IIb, Randomized, Double-blind, Parallel-group Study to Assess the Efficacy, Safety, Tolerability, and Resistance Profile of GSK3640254 in Combination With Dolutegravir Compared to Dolutegravir Plus Lamivudine in HIV-1 Infected, Treatment-naïve Adults

acronym: DYNAMIC

summary: The purpose of this study was to evaluate the efficacy of GSK3640254 + DTG relative to lamivudine (3TC) + DTG in treatment-naïve adult participants living with human immunodeficiency virus (HIV)-1. The participants were randomized to one of the three doses of blinded GSK3640254 (100, 150, or 200 milligrams [mgs]) or a reference arm of blinded 3TC-each in combination with open label DTG.

lead_sponsor: ViiV Healthcare

sponsor_collaborators:
ViiV Healthcare
Syneos Health

location_country:
Germany
Italy
Portugal
Argentina
United States
Spain
South Africa
Canada
Puerto Rico
France


title: A 104-Week, Multicenter, Single-Arm, Long-Term, Phase 3 Extension Trial Investigating the Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Completing the EASE SBS 2 Trial

acronym: EASE SBS 3

summary: This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) for approximately 2 years.

status: Enrolling by invitation

lead_sponsor: Zealand Pharma

location_country:
Germany
Poland
United Kingdom
Denmark
Netherlands
Belgium
United States
France

location_facility: Vanderbilt University Medical Center, Nashville

location_facility: Norfolk and Norwich University Hospitals

location_facility: Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

location_facility: Szpital Skawina sp. z o.o. im. Stanley Dudricka


title: Lead EvaluAtion for Defibrillation and Reliability (LEADR)

summary: The study is designed to assess the safety and efficacy of the Next Generation ICD lead.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Germany
Italy
Portugal
United Kingdom
Hong Kong
Denmark
Australia
Japan
Singapore
Austria
United States
China
Spain
Malaysia
Canada
Serbia
France

location_facility: Institut Jantung Negara - National Heart Institute

location_facility: Virginia Commonwealth University Health System

location_facility: Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology

location_facility: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

location_facility: Saint Luke's Mid America Heart Institute

location_facility: West China Hospital of Sichuan University

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Universitaire de Grenoble - Site Nord

location_facility: Hospital of the University of Pennsylvania

location_facility: National Cerebral and Cardiovascular Center

location_facility: Klinicki Centar Srbije Pejsmejker centar

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Tokyo Women's Medical University Hospital

intervention_type: Device


title: A Phase 1/2 Study Targeting Acquired Resistance Mechanisms in Patients With EGFR Mutant Non-Small Cell Lung Cancer

summary: This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-945, a selective EGFR inhibitor, as monotherapy or in combination with osimertinib.

lead_sponsor: Blueprint Medicines Corporation

location_country:
United Kingdom
Singapore
Japan
Netherlands
United States
China
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Seoul National University, Department of Internal Medicine

location_facility: Institut Claudius Regaud (IUCT-O) - Cancer Comprehensive Center

location_facility: Yonsei Cancer Center, Severance Hospital, Yonsei University

location_facility: Asan Medical Center, Department of Oncology

location_facility: NYU Langone Health, Laura and Isaac Perlmutter Cancer Center

location_facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: The Netherlands Cancer Institute - Antoni van Leeuwenhoek

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: UC Irvine Health, Chao Family Comprehensive Cancer Center

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Vall d'Hebron University Hospital, Oncology Department


summary: An open-label study available to all eligible participants from Study B1371019 and participants originating from Study B1371012 continuing on study intervention with azacitidine with or without glasdegib.

location_facility: Uniklinikum Salzburg, Landeskrankenhaus Salzburg

location_facility: AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek

location_facility: Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU

title: A MULTI-CENTER CONTINUATION STUDY EVALUATING AZACITIDINE WITH OR WITHOUT GLASDEGIB (PF-04449913) IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA, MYELODYSPLASTIC SYNDROME OR CHRONIC MYELOMONOCYTIC LEUKEMIA

location_country:
Italy
Poland
Hungary
United Kingdom
Japan
Austria
Mexico
Spain
Czechia
Canada
France


title: A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Acromegaly Treated With Long-acting Somatostatin Receptor Ligands (PATHFNDR-1)

summary: A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.

lead_sponsor: Crinetics Pharmaceuticals Inc.

location_country:
Italy
Poland
Hungary
Argentina
Israel
United Kingdom
Brazil
Belgium
United States
Peru
Bulgaria
Serbia
Russian Federation
France


title: European Registry of Type A Aortic Dissection

acronym: ERTAAD

summary: Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD.

study_type: Observational

time_perspective: Retrospective

ReferenceType: derived

ReferenceCitation: Biancari F, Mariscalco G, Yusuff H, Tsang G, Luthra S, Onorati F, Francica A, Rossetti C, Perrotti A, Chocron S, Fiore A, Folliguet T, Pettinari M, Dell'Aquila AM, Demal T, Conradi L, Detter C, Pol M, Ivak P, Schlosser F, Forlani S, Chetty G, Harky A, Kuduvalli M, Field M, Vendramin I, Livi U, Rinaldi M, Ferrante L, Etz C, Noack T, Mastrobuoni S, De Kerchove L, Jormalainen M, Laga S, Meuris B, Schepens M, El Dean Z, Vento A, Raivio P, Borger M, Juvonen T. European registry of type A aortic dissection (ERTAAD) - rationale, design and definition criteria. J Cardiothorac Surg. 2021 Jun 10;16(1):171. doi: 10.1186/s13019-021-01536-5. Erratum In: J Cardiothorac Surg. 2021 Aug 9;16(1):225.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: University of Udine - Institutional Research Information System

license_normalized: no license

repository_institution: University of Helsinki - Helda

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

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

repository_institution: University of Oulu - University of Oulu Repository - Jultika

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

version: acceptedVersion

repositories_concat: HELDA - Digital Repository of the University of Helsinki;LIRIAS (KU Leuven);PubMed Central;air.uniud.it;irua;oulu.fi

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Helsinki University Central Hospital

collaborators: University Hospital Southampton NHS Foundation Trust

collaborators: Azienda Ospedaliera Universitaria Integrata Verona

collaborators: Centre Hospitalier Universitaire de Besancon

collaborators: Institute for Clinical and Experimental Medicine

collaborators: Northern General Hospital, Herries Road, Sheffield

collaborators: Liverpool Heart and Chest Hospital NHS Foundation Trust

collaborators: Heart Center Leipzig - University Hospital

collaborators: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

location_country:
Germany
Finland
Italy
United Kingdom
Belgium
Spain
Czechia
France

location_facility: Institute of Clinical and Experimental Medicine

location_facility: University Heart & Vascular Centre Hamburg

intervention_type: Procedure

lead_sponsor_type: academique


acronym: Phase 1/2 trial of GEN3014 in relapsed or refractory hematologic malignancies

lead_sponsor: Genmab

summary:
The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3014 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN3014. GEN3014 will be studied in relapsed or refractory multiple myeloma (also known as RRMM) and other blood cancers. The study consists of 3 parts:

The Dose Escalation will test increasing doses of GEN3014 to find a safe dose level to be tested in the other two parts.
Expansion Part A will further test the GEN3014 dose determined from the Dose Escalation Part.
Expansion Part B will compare intravenous (IV) GEN3014 with the approved multiple myeloma drug, subcutaneous (SC) daratumumab. Participants in the US will not participate Expansion Part B.

Participants will receive either investigational GEN3014 or daratumumab; none will be given placebo. The study duration will be different for the individual participants. Overall, the study may be ongoing up to 5 years after the last participant's first treatment.

location_facility: University Hospitals Cleveland Medical Center

location_facility: Institute of Oncology, ARENSIA Exploratory Medicine

location_facility: SzSzB Megyei Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz

location_facility: Dél-Pesti Centrumkórház Országos Hematológiai és Infektológiai Intézet

location_facility: Chonnam National University Hwasun Hospital

location_facility: Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika

location_facility: National & Kapodistrian University of Athens

title: An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies

location_country:
Poland
Hungary
Denmark
Australia
Sweden
Netherlands
United States
Korea, Republic of
Spain
Greece
Czechia
Ukraine
Moldova, Republic of
Georgia
France


acronym: TAK-994 Extension and Randomized Withdrawal Study in Adult Subjects With Narcolepsy Type 1

lead_sponsor: Takeda

summary:
Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study.

The main aim of this study is to check if participants have side effects from TAK-994.

Participants will take one of 3 different TAK-994 dose for 8 weeks.

Then, half the participants will continue with their dose of TAK-994 and half will take a placebo. In this study, a placebo will look like a TAK-994 tablet but will not have any medicine in it. Participants will take TAK-994 or placebo for 4 weeks.

Participants will visit the clinic for a final check-up 2 weeks after their last dose of TAK-994 or placebo.

The study doctors will check for side effects from TAK-994 and placebo throughout the study.

Participants will continue to record any narcolepsy symptoms as they did in Part B of the TAK 994-1501 study.

location_facility: Shunkaikai Inoue Hospital Dept of Respiratory Medicine

location_facility: Gokeikai Osaka Kaisei Hospital Dept of Sleep Medicine

location_facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic Dept of Internal Medicine

location_facility: Fakultni nemocnice Hradec Kralove Dept of Neurologicka klinika

location_facility: Jinyukai Kotorii Isahaya Hospital Dept of Psychiatry

location_facility: Florida Pulmonary Research Institute, LLC 300127039

location_facility: Beth Israel Deaconess Medical Center CardioVascular Institute

location_facility: Kyowakai Hannan Hospital Dept of Psychiatry

location_facility: Kurume University Hospital Dept of Neuropsychiatry

location_facility: Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders" 150119420

location_facility: SOUSEIKAI PS Clinic Dept of Internal Medicine

location_facility: Vseobecna fakultni nemocnice v Praze Dept of Neurologicka klinika 1.LF UK a VFN v Praze

location_facility: University of Kansas Medical Center Research Institute, Inc. University of Kansas Hospital

location_facility: Sleep Medicine Specialists of South Florida

location_facility: Yoyogi Sleep Disorder Center Dept of Psychiatry

location_facility: Respiratory Specialists Berks Schuylkill Respiratory Specialists Ltd

location_facility: Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche

location_facility: Medical University of South Carolina (MUSC) PARENT

location_facility: Sleep Support Clinic Dept of Psychosomatic Medicine/Psychiatry

location_facility: Ospedale San Raffaele (San Raffaele Turro) Clinica Neurologica- Div Malattie del Sonno

location_facility: Hospital General de Castellon Servicio de Neurofisiologia

location_facility: Nihon University Itabashi Hospital Dept of Neuropsychiatry

location_facility: Howakai Kuwamizu Hospital Dept of Internal Medicine

location_facility: Sleep Therapy & Research Center 300151246

location_facility: Hospital Universitario Araba Sede Santiago Sleep Unit

location_facility: You Ariyoshi Sleep Clinic Dept of Psychiatry

location_facility: Hopital Roger Salengro - CHU Lille service de neurologie D

location_facility: Ohio Sleep Medicine and Neuroscience Institute 186

location_facility: Hopital Gui de Chauliac Service de Neurologie

location_facility: Keimyung University Dongsan Hospital 300144594

location_facility: Koishikawa Tokyo Hospital Dept of Psychiatry

location_facility: Sleep & Stress Clinic Dept of Psychiatry

location_facility: Hospital Vithas Nuestra Senora de America Neurofisiologia Clinica

location_facility: The Catholic University of Korea, St. Vincent's Hospital 300187879

location_facility: Fort Wayne Neurological Center 150711262

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata U.O.C. Neurologia

location_facility: Hospital Clinic de Barcelona Servicio de Neurologia

location_facility: Terveystalo Helsinki Uniklinikka 300186257

location_facility: Delta Waves Sleep Disorders and Research Center 300148510

title: A Dose-Blind Extension Study With Double-blind, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Safety and Explore the Pharmacokinetics and Pharmacodynamics of TAK-994 in Adults With Narcolepsy With Cataplexy (Narcolepsy Type 1)

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https:// clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Finland
Italy
Hungary
Japan
United States
Korea, Republic of
Spain
Czechia
Canada
France


title: A Phase 2a, Double-blind, Randomised, Placebo-controlled, Efficacy, and Safety Study of Multiple Doses of VIT-2763 in Subjects With Sickle Cell Disease

acronym: ViSionSerenity

summary: The purpose of this study is to investigate the effect of VIT-2763 on markers of hemolysis (breakdown in red blood cells) in sickle cell disease (SCD). The safety, tolerability and clinical beneficial effects of VIT-2763 for the treatment of SCD are also explored.

ReferenceType: background

ReferenceCitation: Nyffenegger N, Zennadi R, Kalleda N, Flace A, Ingoglia G, Buzzi RM, Doucerain C, Buehler PW, Schaer DJ, Durrenberger F, Manolova V. The oral ferroportin inhibitor vamifeport improves hemodynamics in a mouse model of sickle cell disease. Blood. 2022 Aug 18;140(7):769-781. doi: 10.1182/blood.2021014716.

lead_sponsor: Vifor (International) Inc.

sponsor_collaborators:
Vifor (International) Inc.
Fortrea, Inc.

location_country:
United Kingdom
Lebanon
United States
Greece
France

location_facility:
Investigator Site 103
Investigator Site 603
Investigator Site 714
Investigator Site 305
Investigator Site 711
Investigator site 301
Investigator Site 713
Investigator Site 703
Investigator Site 709
Investigator Site 101
Investigator Site 802
Investigator Site 801
Investigator Site 607
Investigator Site 706
Investigator Site 708
Investigator Site 302
Investigator Site 601
Investigator Site 608
Investigator Site 606
Investigator Site 605
Investigator Site 701
Investigator Site 102
Investigator Site 702


title: Study Evaluating the Prevalence of the KIT D816V Mutation in Peripheral Blood of Patients With Evidence of Systemic Mast Cell Activation (MCA)

summary: This is a multi-center screening study with the primary objective to determine the prevalence of KIT D816V mutation in peripheral blood in patients with evidence of systemic mast cell activation (MCA).

time_perspective: Prospective

location_country:
Germany
Italy
United Kingdom
Switzerland
Belgium
United States
Spain
France

location_facility: Klinik fuer Dermatologie und Allergologie

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

location_facility: Duke University: Duke Allergy Asthma Airway Center

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Medizinische Hochschule Hannover, Dept. of Dermatology and Allergy

location_facility: Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center HICCC

location_facility: AOU San Giovanni di Dio e Ruggi d'Aragona University of Salerno

intervention_type: Other


title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

summary: This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.

lead_sponsor: Concert Pharmaceuticals

location_country:
Germany
Poland
Hungary
United States
Spain
Canada
France

location_facility: Wromedica I. Bielicka, A. Strzalkowska S.C.

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Szte Áok Szent-Györgyi Albert Klinikai Központ Bőrgyógyászati És Allergológiai Klinika

location_facility: The Rector and Visitors of the University of Virginia

location_facility: Ot.Co Clinic Klinika Osipowicz & Turkowski Sp. Z O.O.

location_facility: Fachklinik Bad Bentheim - Dermatologische Studienambulanz

location_facility: Twoja Przychodnia - Centrum Medyczne Nowa Sól

location_facility: Hospital Universitario Ramón Y Cajal - Edificio Consultas Externas

location_facility: North Texas Center for Clinical Research

location_facility: Columbia University Medical Center - Department of Dermatology

location_facility: Klinikum Rechts Der Isar, Technische Universität München

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitan

location_facility: Universitätsklinikum Frankfurt Klinik Für Dermatologie, Venerologie Und Allergologie

location_facility: Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin

location_facility: Velocity Clinical Research/Swinyer-Woseth Dermatology

location_facility: Pécsi Tudományegyetem Klinikai Központ, Bőr-, Nemikórtani És Onkodermatológiai Klinika

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Semmelweis Egyetem, Általános Orvostudományi Kar, Bőr-, Nemikórtani És Bőronkológiai Klinika

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital Archet 2


title: A Phase 1 Open-label, Multicenter Study Evaluating the Safety of KITE-222, an Autologous Anti-CLL-1 CAR T-cell Therapy, in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

summary: The goal of this clinical study is to learn more about the safety and dosing of the study drug, KITE-222, in participants with relapsed/refractory (r/r) acute myeloid leukemia (AML).

lead_sponsor: Kite, A Gilead Company

location_country:
United States
France

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Washington University School of Medicine

location_facility: CHU de Toulouse Institut Universitaire du Cancer Toulouse Oncopole

location_facility: The Ohio State University Wexner Medical Center/James Cancer Hospital


title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia

summary: This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Germany
Italy
Norway
United Kingdom
Netherlands
Switzerland
United States
Canada
France

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Dresden Center for Islet Transplantation

location_facility: University of Pittsburgh Medical Center Montefiore

location_facility: Hospital of the University of Pennsylvania


title: A Phase 1, Multi-center, Open Label First-in-Human Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors

summary:
The study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI).

The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy).

Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors.

Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors.

Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.

lead_sponsor: Calico Life Sciences LLC

sponsor_collaborators:
Calico Life Sciences LLC
AbbVie

location_country:
France
Japan
United States
Korea, Republic of
Spain
Israel

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine

location_facility: Lifespan Cancer Institute at Rhode Island Hospital


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE)

acronym: ENERGIZE

summary: The primary purpose of this study is to compare the effect of mitapivat versus placebo on anemia in participants with alpha- or beta-non-transfusion dependent thalassemia (NTDT).

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Italy
United Kingdom
Denmark
Brazil
Netherlands
Lebanon
United Arab Emirates
United States
Saudi Arabia
Spain
Thailand
Greece
Malaysia
Turkey
Taiwan
Bulgaria
Canada
France

location_facility: Toronto General Hospital, University Health Network

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: Instituto do Cancer do Estado de São Paulo, Hospital das Clínicas da Faculdade de Medicina da Universidad de São Paulo

location_facility: HEMORIO Instituto Nacional de Hematologia

location_facility: Children's Hospital Agia Sophia, National and Kapodistrian University of Athens Medical School

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli

location_facility: Penn Medicine - University of Pennsylvania Health System

location_facility: Manchester Royal Infirmary, Manchester University NHS Foundation Trust

location_facility: King Abdullah International Medical Research Center

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Srinagarind Hospital, Khon Kaen University


title: STARSTIM: SAFETY AND THERAPEUTIC MEASURES OF TRANSCRANIAL CATHODAL DIRECT CURRENT STIMULATION (TDCS) IN PATIENTS WITH REFRACTORY FOCAL EPILEPSY

summary: This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.

ipd_sharing: Undecided

lead_sponsor: Neuroelectrics Corporation

location_country:
United States
Spain
Belgium
France

location_facility: Robert Wood Johnson Medical School (Rutgers)

location_facility: Southern Illinois University School of Medicine

location_facility: Boston Children's Hospital Comprehensive Epilepsy Center

location_facility: University of Pennsylvania (Penn Epilepsy)

location_facility: Seattle Children's Hospital, University of Washington

location_facility: Barrow Neurological Institute, St. Joseph's Hospital & Medical Center


acronym: eMonarcHER

lead_sponsor: Eli Lilly and Company

summary: The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.

location_facility: Fundación Cenit Para La Investigación En Neurociencias

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin

location_facility: Fundación CORI para la Investigación y Prevención del Cáncer

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Tongji Medical College of Huazhong University of Science and Technology

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: West China Hospital of Sichuan University

location_facility: Xiangya Hospital Central South University

location_facility: National Hospital Organization Osaka Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: CHU de Charleroi - Hopital Civil Marie Curie

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Xinjiang Medical University Cancer Hospital - Urumqi

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: TRIO-US (Translational Research in Oncology-US)

title: eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy

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
United Kingdom
Argentina
Japan
Brazil
Switzerland
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
France


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion

acronym: BALATON

summary: This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

lead_sponsor: Hoffmann-La Roche

sponsor_collaborators:
Hoffmann-La Roche
Chugai Pharmaceutical

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Czechia
France
Portugal
Hungary
Hong Kong
United States
China
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Hospital dos de maig; servicio de oftalmologia

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Queen Mary Hospital; Department of Ophthalmology

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Eye Hospital, Wenzhou Medical University

location_facility: The 2nd Affiliated Hospital of Harbin Medical University

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: California Eye Specialists Medical group Inc.

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Retina Consultants of Southern Colorado PC

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: ?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch

location_facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

location_facility: Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: University Retina and Macula Associates, PC

location_facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

location_facility: Centro Hospitalar Universitário do Porto ? Hospital de Santo António; Servico de Oftalmologia

location_facility: National Taiwan University Hospital; Ophthalmology

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: Tan Tock Seng Hospital; Ophthalmology Department

location_facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Specjalistyczny O?rodek Okulistyczny Oculomedica

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: The Affiliated Eye Hospital of Nanjing Medical University

location_facility: Zhongshan Ophthalmic Center, Sun Yat-sen University

location_facility: Faculty Hospital Ostrava; Ophthalmology clinic

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Bristol Eye Hospital;Retinal Treatment and Research Unit

location_facility: Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia


acronym: RISE

lead_sponsor: Mirum Pharmaceuticals, Inc.

summary: This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].

location_facility: University of California - San Francisco

location_facility: Consultorio de Joshue David Covarrubias Esquer

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio-Libanês

title: Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome

location_country:
Poland
United Kingdom
Brazil
Mexico
Belgium
United States
France


title: WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)

summary: The WE-TRUST study is a multi-center randomized clinical trial to assess the impact of a Direct to Angio Suite (DTAS) workflow on stroke patient outcomes.

primary_purpose: Diagnostic

lead_sponsor: Philips Clinical & Medical Affairs Global

location_country:
Germany
Argentina
Brazil
Netherlands
United States
Spain
Turkey
France

location_facility: İstanbul Aydin University medical park florya hospital

location_facility: Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba

location_facility: Grady Memorial Hospital/Emory University


title: A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

acronym: ADVANCE SC

summary: This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.

lead_sponsor: argenx

location_country:
Germany
Ireland
Poland
Taiwan
New Zealand
Argentina
Australia
Japan
Thailand
Turkey
Chile
Serbia
France
Portugal
Denmark
United States
Romania
Tunisia
China
Italy
Norway
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
South Africa
Jordan
Bulgaria
Georgia
Russian Federation
Israel

location_facility:
Investigator Site 0860005
Investigator Site 0270002
Investigator Site 0390015
Investigator Site 0390041
Investigator Site 0610001
Investigator Site 0340007
Investigator Site 0520004
Investigator site 0390014
Investigator Site 0010095
Investigator Site 0540001
Investigator Site 0610012
Investigator Site 0330018
Investigator Site 0610004
Investigator Site 0660005
Investigator Site 0010102
Investigator Site 9950011
Investigator Site 0900016
Investigator Site 0340004
Investigator Site 0900013
Investigator Site 0520003
Investigator Site 0440008
Investigator Site 0820007
Investigator Site 0860008
Investigator Site 9950007
Investigator Site 0400006
Investigator Site 0390043
Investigator Site 0900006
Investigator Site 0860011
Investigator Site 0660008
Investigator Site 0070012
Investigator Site 0860012
Investigator Site 0480013
Investigator Site 0860013
Investigator Site 0820008
Investigator Site 0470003
Investigator Site 3530001
Investigator Site 0480039
Investigator Site 9720011
Investigator site 0010193
Investigator Site 9950008
Investigator Site 0610003
Investigator Site 0900019
Investigator Site 0660002
Investigator Site 0010116
Investigator Site 0610009
Investigator Site 9720008
Investigator Site 0340006
Investigator site 0010040
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title: An Adaptive Phase 2, Randomized, Double Blind, Placebo Controlled Study of LY3471851 (NKTR 358) in Patients With Moderately to Severely Active Ulcerative Colitis

acronym: INSTRUCT-UC

summary: The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study treatment will last about 52 weeks.

lead_sponsor: Nektar Therapeutics

sponsor_collaborators:
Nektar Therapeutics
Eli Lilly and Company

location_country:
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Slovakia
Hungary
United States
Latvia
Ukraine
India
Romania
Belgium
China
United Kingdom
Korea, Republic of
Georgia
Russian Federation
Israel

location_facility: Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: SR Kalla Memorial Gastro & General Hospital

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

location_facility: CHU De Grenoble Hopital Albert Michallon

location_facility: Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

location_facility: Centre Hospitalier de Wallonie Picarde - Site Notre Dame

location_facility: Gastroenterology and internal medicine research institute

location_facility: Gujarat Hospital - Gastro and Vascular Centre

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

location_facility: Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS

location_facility: The Sixth Affiliated Hospital, Sun Yat-Sen University

location_facility: GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health

location_facility: CISSS de la Montérégie - Centre Hôpital Charles-Le Moyne

location_facility: Acad. F. Todua Medical Center - Research Institute of Clinical Medicine

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Vinnytsia War Veterans Regional Clinical Hospital

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Gastroenterology Research, Nova Scotia Health Authority

location_facility: Open Joint Stock Company Clinical and Diagnostic Center Euromedservice

location_facility: International Institute of Clinical Trials LLC

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Medical Center of LLC Medical Center Clinic of Family Medicine

location_facility: Université Libre de Bruxelles - Hôpital Erasme


title: An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

summary: This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator.

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Colombia
Brazil
Lebanon
Belgium
United States
Spain
Turkey
Oman
France


title: An Exploratory, Open-label, Multicenter Phase 1b Trial to Evaluate Safety and Efficacy of Sym021 (Anti-PD 1) in Combination With Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3) or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies

summary: The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC) and with esophageal squamous cell carcinoma (ESCC) by assessing overall response rates (ORRs) per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 The study will also evaluate the safety and tolerability profile of the 3 combinations

lead_sponsor: Symphogen A/S

location_country:
United States
Spain
Canada
France

location_facility: University of Kansas Medical Center (KUMC)

location_facility: Centre Georges-François Leclerc, Department of Medical Oncology


title: An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib

summary: This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline/TESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Israel
Denmark
Austria
United States
Spain
Canada
France


title: International Chemotherapy Induced Peripheral Neurotoxicity (CIPN) Assessment and Validation Study

acronym: ICAVS

summary: This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.

lead_sponsor: University of Milano Bicocca

location_country:
Germany
Italy
Portugal
Denmark
Australia
Brazil
Switzerland
Austria
United States
Kenya
Korea, Republic of
Bangladesh
Greece
Spain
Canada
France

location_facility: University of Michigan School of Nursing

location_facility: Cancer Center/Wexner Medical Center - Ohio State Medical Oncology Division

location_facility: International Centre for Diarrhoeal Disease Research

location_facility: University of Basel - Department of Sport, Exercise and Health

location_facility: Birmingham School of Nursing, University of Alabama

location_facility: Hospital Universitari de Bellvitge-ICO L'Hospitalet

location_facility: Medical Oncoloy Unit - University of Nairobi

location_facility: Dept. of Neurology, Medical University of Vienna

location_facility: Dong-A University - Internal Medicine Dept.

location_facility: Columbia University Irving Medical Center

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho