title: A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1]

summary: The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).

ReferenceCitation: Rabe KF, Chalmers JD, Miravitlles M, Kocks JWH, Tsiligianni I, de la Hoz A, Xue W, Singh D, Ferguson GT, Wedzicha J. Tiotropium/Olodaterol Delays Clinically Important Deterioration Compared with Tiotropium Monotherapy in Patients with Early COPD: a Post Hoc Analysis of the TONADO(R) Trials. Adv Ther. 2021 Jan;38(1):579-593. doi: 10.1007/s12325-020-01528-2. Epub 2020 Nov 11.

repository_institution: University of Dundee - Discovery Research Portal

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repositories_institution: University of Dundee - Discovery Research Portal

ReferenceCitation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

repository_institution: Imperial College London - Spiral

ReferenceCitation: Andreas S, Bothner U, de la Hoz A, Kloer I, Trampisch M, Alter P. No Influence on Cardiac Arrhythmia or Heart Rate from Long-Term Treatment with Tiotropium/Olodaterol versus Monocomponents by Holter ECG Analysis in Patients with Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1945-1953. doi: 10.2147/COPD.S246350. eCollection 2020.

ReferenceCitation: Andreas S, McGarvey L, Bothner U, Trampisch M, de la Hoz A, Flezar M, Buhl R, Alter P. Absence of Adverse Effects of Tiotropium/Olodaterol Compared with the Monocomponents on Long-Term Heart Rate and Blood Pressure in Patients with Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1935-1944. doi: 10.2147/COPD.S246348. eCollection 2020.

repository_institution: Queen's University Belfast - Research Portal

repositories_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Wedzicha JA, Buhl R, Singh D, Vogelmeier CF, de la Hoz A, Xue W, Anzueto A, Calverley PMA. Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO(R)/DYNAGITO(R) Trials. Adv Ther. 2020 Oct;37(10):4266-4279. doi: 10.1007/s12325-020-01438-3. Epub 2020 Aug 10.

repository_institution: University of Illinois at Chicago - INDIGO

repositories_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Buhl R, de la Hoz A, Xue W, Singh D, Ferguson GT. Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naive to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials. Adv Ther. 2020 Oct;37(10):4175-4189. doi: 10.1007/s12325-020-01411-0. Epub 2020 Jul 15.

ReferenceCitation: Buhl R, Singh D, de la Hoz A, Xue W, Ferguson GT. Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO(R) and OTEMTO(R) Studies. Adv Ther. 2020 Aug;37(8):3485-3499. doi: 10.1007/s12325-020-01373-3. Epub 2020 May 27.

ReferenceCitation: Ferguson GT, Buhl R, Bothner U, Hoz A, Voss F, Anzueto A, Calverley PMA. Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. Respir Med. 2018 Oct;143:67-73. doi: 10.1016/j.rmed.2018.08.012. Epub 2018 Aug 28.

ReferenceCitation: Maltais F, Buhl R, Koch A, Amatto VC, Reid J, Gronke L, Bothner U, Voss F, McGarvey L, Ferguson GT. beta-Blockers in COPD: A Cohort Study From the TONADO Research Program. Chest. 2018 Jun;153(6):1315-1325. doi: 10.1016/j.chest.2018.01.008. Epub 2018 Jan 31.

ReferenceCitation: Buhl R, Magder S, Bothner U, Tetzlaff K, Voss F, Loaiza L, Vogelmeier CF, McGarvey L. Long-term general and cardiovascular safety of tiotropium/olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease. Respir Med. 2017 Jan;122:58-66. doi: 10.1016/j.rmed.2016.11.011. Epub 2016 Nov 14.

ReferenceCitation: Ferguson GT, Flezar M, Korn S, Korducki L, Gronke L, Abrahams R, Buhl R. Efficacy of Tiotropium + Olodaterol in Patients with Chronic Obstructive Pulmonary Disease by Initial Disease Severity and Treatment Intensity: A Post Hoc Analysis. Adv Ther. 2015 Jun;32(6):523-36. doi: 10.1007/s12325-015-0218-0. Epub 2015 Jun 26.

ReferenceCitation: Buhl R, Maltais F, Abrahams R, Bjermer L, Derom E, Ferguson G, Flezar M, Hebert J, McGarvey L, Pizzichini E, Reid J, Veale A, Gronke L, Hamilton A, Korducki L, Tetzlaff K, Waitere-Wijker S, Watz H, Bateman E. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur Respir J. 2015 Apr;45(4):969-79. doi: 10.1183/09031936.00136014. Epub 2015 Jan 8. Erratum In: Eur Respir J. 2015 Jun;45(6):1763.

repository_institution: Lund University - Lund University Publications

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_institution: Lund University - Lund University Publications

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Japan
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Canada
France
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Slovenia
Portugal
Hungary
Denmark
United States
India
China
Estonia
Italy
Guatemala
Netherlands
Mexico
Korea, Republic of
Bulgaria
Russian Federation

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title: A Multi-center, Longitudinal, Observational Study of Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics, and Determinants of Disease Progression

acronym: OVERTURE

summary: To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Czech Republic
Switzerland
United States
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Spain
Sweden

location_facility:
Otuska Investigational Site
Otsuka Investigational Site 2
Otsuka Investigational Site
Otsuka Investigational Sites
Otsuka Investigational Site 1

lead_sponsor_type: industriel

status_simplified: Completed


acronym: LAIF

intervention_type: Drug

lead_sponsor: Swedish Orphan Biovitrum

summary: The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.

ReferenceType: derived

ReferenceCitation: Casper C, Hascoet JM, Ertl T, Gadzinowski JS, Carnielli V, Rigo J, Lapillonne A, Couce ML, Vagero M, Palmgren I, Timdahl K, Hernell O. Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study. PLoS One. 2016 May 31;11(5):e0156071. doi: 10.1371/journal.pone.0156071. eCollection 2016.

oa_colors: green gold

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license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ParisTech

repository_normalized: HAL

repository_institution: Umeå University - DiVA at Umeå University

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

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evidence: oa repository (semantic scholar lookup)

version: submittedVersion

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

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

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Wolters Kluwer Health

location_facility: Swedish Orphan Biovitrum Investigational Site

status: Terminated

title: A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

primary_purpose: Treatment

source: euctr

design_allocation: Randomized

location_country:
Germany
Italy
Poland
Hungary
Sweden
Belgium
Spain
Czech Republic
Russian Federation
France

study_type: Interventional

status_simplified: Unknown


type: EudraCT Number

title: A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma

summary: The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.

ReferenceType: background

ReferenceCitation: Brightling CE, Chanez P, Leigh R, O'Byrne PM, Korn S, She D, May RD, Streicher K, Ranade K, Piper E. Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Respir Med. 2015 Sep;3(9):692-701. doi: 10.1016/S2213-2600(15)00197-6. Epub 2015 Jul 28.

ReferenceCitation: Baverel PG, White N, Vicini P, Karlsson MO, Agoram B. Dose-Exposure-Response Relationship of the Investigational Anti-Interleukin-13 Monoclonal Antibody Tralokinumab in Patients With Severe, Uncontrolled Asthma. Clin Pharmacol Ther. 2018 May;103(5):826-835. doi: 10.1002/cpt.803. Epub 2017 Sep 28.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

lead_sponsor: MedImmune LLC

location_country:
France
Germany
Poland
Russian Federation
United Kingdom
Argentina
Japan
Mexico
United States
Korea, Republic of
Spain
Chile
Canada
Philippines
Czech Republic

intervention_type: Biological


title: A Multicenter, Prospective Cohort Study Using Nailfold VideoCAPillaroscopy(NVC) and Other Factors to Determine the Risk of Developing Digital Ulceration in Patients With Systemic Sclerosis (SSc)

acronym: CAP

summary: The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.

lead_sponsor: Actelion

location_country:
Germany
Italy
Portugal
Israel
Norway
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Spain
Greece
Turkey
Czech Republic
France

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Universitätsklinik für Innere Medizin Wien

location_facility: Centre Hospitalier Universitaire Vaudoise

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Sankt Josef-Hospital, Klinikum der Ruhr-Universität Bochum

location_facility: Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln

location_facility: Groupe Hospitalier Cochin Saint Vincent de Paul

location_facility: Université Libre de Bruxelles Hopital Erasme

location_facility: Hanusch Krankenhaus der Gebietskrankenkasse

location_facility: Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro

location_facility: CHRU de Lille, hopital Claude Huriez, Service des maladies du sang

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi


title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 12 Weeks in Hypertensive Patients With Type 2 Diabetes Mellitus

summary: This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

oa_colors: green other

evidence: open (via free pdf)

evidence: oa repository (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_institution: University College London - UCL Discovery

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

ReferenceCitation: Mancia G, Cannon CP, Tikkanen I, Zeller C, Ley L, Woerle HJ, Broedl UC, Johansen OE. Impact of Empagliflozin on Blood Pressure in Patients With Type 2 Diabetes Mellitus and Hypertension by Background Antihypertensive Medication. Hypertension. 2016 Dec;68(6):1355-1364. doi: 10.1161/HYPERTENSIONAHA.116.07703. Epub 2016 Oct 10.

oa_host_type: publisher

ReferenceCitation: Tikkanen I, Narko K, Zeller C, Green A, Salsali A, Broedl UC, Woerle HJ; EMPA-REG BP Investigators. Empagliflozin reduces blood pressure in patients with type 2 diabetes and hypertension. Diabetes Care. 2015 Mar;38(3):420-8. doi: 10.2337/dc14-1096. Epub 2014 Sep 30.

ipd_sharing: Yes

ipd_sharing_description: Boehringer Ingelheim Policy on Transparency and Publication http://trials.boehringer-ingelheim.com/transparency_policy.html

lead_sponsor: Boehringer Ingelheim

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_country:
Finland
France
Germany
Norway
Denmark
Sweden
Netherlands
Lebanon
United States
Canada
Estonia
Czech Republic

location_facility: 1245.48.31011 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35807 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.37201 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10019 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10011 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.96002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10027 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10032 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10029 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10035 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10033 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10016 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45010 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35805 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10024 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31010 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10026 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31012 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35803 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10034 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10013 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10042 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.96003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10020 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31015 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.37204 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10030 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35804 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31016 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10010 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31013 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31014 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10025 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.37202 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10018 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31017 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49010 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10041 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10012 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35802 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10017 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10023 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10039 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35806 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10022 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10036 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10014 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.96001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35801 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31019 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.37203 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45003 Boehringer Ingelheim Investigational Site


type: Other Identifier

title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin , Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease

summary: This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin + bevacizumab therapy in patients with histologically or cytologically documented inoperable, locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.

ReferenceCitation: von Pawel J, Spigel DR, Ervin T, Losonczy G, Barlesi F, Juhasz E, Anderson M, McCall B, Wakshull E, Hegde P, Ye W, Chen D, Chang I, Rhee I, Reck M. Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with Carboplatin, Paclitaxel, and Bevacizumab for First-Line Nonsquamous Non-Small Cell Lung Cancer. Oncologist. 2018 Jun;23(6):654-e58. doi: 10.1634/theoncologist.2017-0690. Epub 2018 Feb 7.

evidence: open (via free article)

license: unspecified-oa

license_normalized: unspecified-oa

publisher_dissemination: Oxford University Press

lead_sponsor: Genentech, Inc.

location_country:
Germany
Poland
Hungary
Australia
United States
Czech Republic
France


title: A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared With Docetaxel in 2nd Line Subjects With Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC Stage IV)

summary: This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and safety of GSK1120212 compared with docetaxel in the second line setting for subjects with locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS mutation who have failed one platinum-containing chemotherapy regimen. A small subset of NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the primary KRAS population, for exploratory purposes.

ReferenceCitation: Blumenschein GR Jr, Smit EF, Planchard D, Kim DW, Cadranel J, De Pas T, Dunphy F, Udud K, Ahn MJ, Hanna NH, Kim JH, Mazieres J, Kim SW, Baas P, Rappold E, Redhu S, Puski A, Wu FS, Janne PA. A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) compared with docetaxel in KRAS-mutant advanced non-small-cell lung cancer (NSCLC)dagger. Ann Oncol. 2015 May;26(5):894-901. doi: 10.1093/annonc/mdv072. Epub 2015 Feb 26.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Elsevier

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Hungary
Netherlands
United States
Korea, Republic of
Spain
Greece
France


title: A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression

summary: The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Italy
India
Argentina
Australia
Sweden
Austria
United States
Spain
South Africa
Puerto Rico
France

location_facility: K & S Professional Research Services, Llc

location_facility: Atlanta Institute Of Medicine & Research

location_facility: Oregon Center For Clinical Investigations, Inc (Occi, Inc)

location_facility: Independent Psychiatric Consultants, Sc, Dba, Ipc Research

location_facility: Comprehensive Clinical Development, Inc.

location_facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.

location_facility: Dean Foundation For Health Research & Education

location_facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.

location_facility: Neuropsychiatric Research Center Of Orange County

location_facility: California Neuroscience Research Medical Group, Inc.

location_facility: Oregon Center For Clinical Investigations, Inc. (Occi, Inc)

location_facility: Collaborative Neuroscience Network, Inc.


title: A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial

acronym: Orion

summary: To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)

study_start_date_type: Actual

design_allocation: Non-Randomized

ReferenceCitation: Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6):18m12680. doi: 10.4088/JCP.18m12680.

publisher_dissemination: Physicians Postgraduate Press, Inc

ipd_sharing: No

sponsor_collaborators: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Germany
Poland
Slovakia
Hungary
Romania
United States
Canada
Ukraine
Serbia
Russian Federation
France


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (mCRPC)

acronym: PERSEUS

summary: The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

lead_sponsor: EMD Serono

location_country:
Germany
Poland
Slovakia
Australia
Netherlands
Belgium
United States
Spain
South Africa
Canada
Russian Federation
France

location_facility: Hôpitaux Civils de Colmar-CH Louis Pasteur

location_facility: Universitätsmedizin Charité, Campus Benjamin Franklin, Urologische Klinik and Poliklinik

location_facility: Universitätsklinikum Tübinger, Klinik und Poliklinik für Urologie

location_facility: Krasnoyarsk State Medical University Oncology and Radiotherapy Territorial Dispensary

location_facility: State Institution of Healthcare Ivanovo Regional Oncology Dispensary

location_facility: Universitätsklinikum Carl Gustav Carus an der Techischen Universität Dresden, Klinik und Poliklinik für Urologie


title: A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

acronym: FIXTURE

summary: This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repositories_concat: PubMed Central;eprints.gla.ac.uk

publisher_dissemination: Springer-Nature

ReferenceCitation: Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.

ReferenceCitation: Dehlin M, Fasth AER, Reinhardt M, Jacobsson LTH. Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis-a post-hoc analysis of pooled data from three phase 3 trials with secukinumab. Rheumatol Adv Pract. 2021 Feb 18;5(1):rkab009. doi: 10.1093/rap/rkab009. eCollection 2021.

ReferenceCitation: Augustin M, Thaci D, Eyerich K, Pinter A, Radtke M, Lauffer F, Mrowietz U, Gerdes S, Pariser D, Lebwohl M, Sieder C, Melzer N, Reich K. Continued treatment with secukinumab is associated with high retention or regain of response. Br J Dermatol. 2020 Jan;182(1):67-75. doi: 10.1111/bjd.17991. Epub 2019 Jul 17.

ReferenceCitation: Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. doi: 10.1007/s13555-016-0140-7. Epub 2016 Aug 30.

ReferenceCitation: Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. doi: 10.1007/s13555-016-0139-0. Epub 2016 Aug 30.

ReferenceCitation: Gottlieb AB, Langley RG, Philipp S, Sigurgeirsson B, Blauvelt A, Martin R, Papavassilis C, Mpofu S. Secukinumab Improves Physical Function in Subjects With Plaque Psoriasis and Psoriatic Arthritis: Results from Two Randomized, Phase 3 Trials. J Drugs Dermatol. 2015 Aug;14(8):821-33.

ReferenceCitation: Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, Puig L, Nakagawa H, Spelman L, Sigurgeirsson B, Rivas E, Tsai TF, Wasel N, Tyring S, Salko T, Hampele I, Notter M, Karpov A, Helou S, Papavassilis C; ERASURE Study Group; FIXTURE Study Group. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. doi: 10.1056/NEJMoa1314258. Epub 2014 Jul 9.

location_country:
Finland
Germany
Poland
Argentina
Australia
Canada
France
Colombia
Hungary
United States
Iceland
India
Romania
Belgium
Philippines
Egypt
Italy
Guatemala
United Kingdom
Singapore
Korea, Republic of
Spain
Sweden


title: An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML).

summary: The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.

location_country:
Finland
Poland
Argentina
Belgium
United States
Spain
Canada
France

location_facility:
Tennessee Oncology Pllc
Huntsman Cancer Institute
Local Institution
John Theurer Cancer Center


title: A 12-week Study to Evaluate the 24 Hour Pulmonary Function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared With Salmeterol/Fluticasone Propionate (FP) Inhalation Powder Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

summary: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.

ReferenceCitation: Agusti A, de Teresa L, De Backer W, Zvarich MT, Locantore N, Barnes N, Bourbeau J, Crim C. A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD. Eur Respir J. 2014 Mar;43(3):763-72. doi: 10.1183/09031936.00054213. Epub 2013 Oct 10.

publisher_dissemination: European Respiratory Society

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

location_country:
Germany
Italy
Poland
Russian Federation
Belgium
Spain
Ukraine
Philippines
France


title: A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder.

acronym: Symphony

summary: The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.

ReferenceCitation: Abrams P, Kelleher C, Staskin D, Rechberger T, Kay R, Martina R, Newgreen D, Paireddy A, van Maanen R, Ridder A. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). Eur Urol. 2015 Mar;67(3):577-88. doi: 10.1016/j.eururo.2014.02.012. Epub 2014 Feb 19.

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

lead_sponsor: Astellas Pharma Europe B.V.

location_country:
Finland
Germany
Poland
Czechia
France
Belarus
Portugal
Slovakia
Hungary
Denmark
Ukraine
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Spain
Russian Federation
Sweden


title: A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary:
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

ReferenceCitation: Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

ReferenceCitation: Jouneau S, Crestani B, Thibault R, Lederlin M, Vernhet L, Valenzuela C, Wijsenbeek M, Kreuter M, Stansen W, Quaresma M, Cottin V. Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis. Respir Res. 2020 Nov 25;21(1):312. doi: 10.1186/s12931-020-01528-4.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

ReferenceCitation: Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6):2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun.

evidence: open (via crossref license)

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: Richeldi L, Kolb M, Jouneau S, Wuyts WA, Schinzel B, Stowasser S, Quaresma M, Raghu G. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis. BMC Pulm Med. 2020 Jan 8;20(1):3. doi: 10.1186/s12890-019-1030-4.

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
publicatt.unicatt.it

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central;publicatt.unicatt.it

repositories_institution: Università Cattolica del Sacro Cuore - PubliCatt

ReferenceCitation: Kreuter M, Koegler H, Trampisch M, Geier S, Richeldi L. Differing severities of acute exacerbations of idiopathic pulmonary fibrosis (IPF): insights from the INPULSIS(R) trials. Respir Res. 2019 Apr 11;20(1):71. doi: 10.1186/s12931-019-1037-7.

repository_institution: Heidelberg University - heiDOK - The Heidelberg Document Repository

ReferenceCitation: Xu Z, Li H, Wen F, Bai C, Chen P, Fan F, Hu N, Stowasser S, Kang J. Subgroup Analysis for Chinese Patients Included in the INPULSIS(R) Trials on Nintedanib in Idiopathic Pulmonary Fibrosis. Adv Ther. 2019 Mar;36(3):621-631. doi: 10.1007/s12325-019-0887-1. Epub 2019 Feb 7.

ReferenceCitation: Costabel U, Behr J, Crestani B, Stansen W, Schlenker-Herceg R, Stowasser S, Raghu G. Anti-acid therapy in idiopathic pulmonary fibrosis: insights from the INPULSIS(R) trials. Respir Res. 2018 Sep 3;19(1):167. doi: 10.1186/s12931-018-0866-0.

ReferenceCitation: Collard HR, Richeldi L, Kim DS, Taniguchi H, Tschoepe I, Luisetti M, Roman J, Tino G, Schlenker-Herceg R, Hallmann C, du Bois RM. Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis. Eur Respir J. 2017 May 19;49(5):1601339. doi: 10.1183/13993003.01339-2016. Print 2017 May.

ReferenceCitation: Paterniti MO, Bi Y, Rekic D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

ReferenceCitation: Rinciog C, Watkins M, Chang S, Maher TM, LeReun C, Esser D, Diamantopoulos A. A Cost-Effectiveness Analysis of Nintedanib in Idiopathic Pulmonary Fibrosis in the UK. Pharmacoeconomics. 2017 Apr;35(4):479-491. doi: 10.1007/s40273-016-0480-2.

repositories:
PubMed Central
UCL Discovery
spiral.imperial.ac.uk

ReferenceCitation: Kolb M, Richeldi L, Behr J, Maher TM, Tang W, Stowasser S, Hallmann C, du Bois RM. Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume. Thorax. 2017 Apr;72(4):340-346. doi: 10.1136/thoraxjnl-2016-208710. Epub 2016 Sep 26.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

repository_institution: University of Southampton - ePrints Soton

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Southampton - ePrints Soton

ReferenceCitation: Corte T, Bonella F, Crestani B, Demedts MG, Richeldi L, Coeck C, Pelling K, Quaresma M, Lasky JA. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. 2015 Sep 24;16:116. doi: 10.1186/s12931-015-0276-5.

ReferenceCitation: Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82. doi: 10.1056/NEJMoa1402584. Epub 2014 May 18. Erratum In: N Engl J Med. 2015 Aug 20;373(8):782.

ReferenceCitation: Richeldi L, Cottin V, Flaherty KR, Kolb M, Inoue Y, Raghu G, Taniguchi H, Hansell DM, Nicholson AG, Le Maulf F, Stowasser S, Collard HR. Design of the INPULSIS trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis. Respir Med. 2014 Jul;108(7):1023-30. doi: 10.1016/j.rmed.2014.04.011. Epub 2014 Apr 29.

location_country:
France
Germany
Ireland
Italy
India
Israel
United Kingdom
Australia
Japan
Belgium
United States
China
Czech Republic

location_facility: 1199.32.42001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10034 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.86006 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10016 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.97001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.86005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10015 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.35301 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.97004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81009 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39012 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81006 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10007 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.61005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44006 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10024 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10025 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.91002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10028 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10018 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81011 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39006A Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39006B Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10013 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.42003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81008 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44008 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39010 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.86002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.61001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.42002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.32005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81010 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.86001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81012 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10008 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.97002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.91005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.91006 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39009 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10033 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.86003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33007 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44009 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.32001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49008 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10019 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39008 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39007 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39011 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81007 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10009 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10023 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.61003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.91001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10038 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.86004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49007 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33006 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10021 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10029 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10020 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.61002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.91003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.32002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.61004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.32004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10022 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39005 Boehringer Ingelheim Investigational Site


acronym: GALLIUM

lead_sponsor: Hoffmann-La Roche

summary: This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants achieving response (Complete response [CR] or partial response [PR]) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study.

ReferenceCitation: Casulo C, Herold M, Hiddemann W, Iyengar S, Marcus RE, Seymour JF, Launonen A, Knapp A, Nielsen TG, Mir F. Risk Factors for and Outcomes of Follicular Lymphoma Histological Transformation at First Progression in the GALLIUM Study. Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):40-48. doi: 10.1016/j.clml.2022.09.003. Epub 2022 Oct 4.

ReferenceCitation: Hong X, Song Y, Shi Y, Zhang Q, Guo W, Wu G, Li J, Feng J, Kinkolykh A, Knapp A, Lin T. Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma: a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study. Chin Med J (Engl). 2021 Sep 16;135(4):433-440. doi: 10.1097/CM9.0000000000001737.

ReferenceCitation: Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trneny M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcgamma receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Davies A, Trask P, Demeter J, Florschutz A, Hanel M, Kinoshita T, Pettengell R, Quach H, Robinson S, Sadullah S, Sancho JM, Udvardy M, Witzens-Harig M, Knapp A, Liu W. Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma. Ann Hematol. 2020 Dec;99(12):2837-2846. doi: 10.1007/s00277-020-04021-6. Epub 2020 Apr 20.

repository_normalized: University of Melbourne - Minerva Access

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: St George's University of London - St George's Online Research Archive

repositories: University of Melbourne - Minerva Access

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;ddd.uab.cat;eprints.soton.ac.uk;openaccess.sgul.ac.uk

ReferenceCitation: Klanova M, Oestergaard MZ, Trneny M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repositories_institution: La Trobe University - OPAL (Open@LaTrobe)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19.

ReferenceCitation: Trotman J, Barrington SF, Belada D, Meignan M, MacEwan R, Owen C, Ptacnik V, Rosta A, Fingerle-Rowson GR, Zhu J, Nielsen T, Sahin D, Hiddemann W, Marcus RE, Davies A; PET investigators from the GALLIUM study. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1530-1542. doi: 10.1016/S1470-2045(18)30618-1. Epub 2018 Oct 8. Erratum In: Lancet Oncol. 2019 Apr 29;:

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

ReferenceCitation: Hiddemann W, Barbui AM, Canales MA, Cannell PK, Collins GP, Durig J, Forstpointner R, Herold M, Hertzberg M, Klanova M, Radford J, Seymour JF, Tobinai K, Trotman J, Burciu A, Fingerle-Rowson G, Wolbers M, Nielsen T, Marcus RE. Immunochemotherapy With Obinutuzumab or Rituximab for Previously Untreated Follicular Lymphoma in the GALLIUM Study: Influence of Chemotherapy on Efficacy and Safety. J Clin Oncol. 2018 Aug 10;36(23):2395-2404. doi: 10.1200/JCO.2017.76.8960. Epub 2018 Jun 1.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, Phillips E, Sangha R, Schlag R, Seymour JF, Townsend W, Trneny M, Wenger M, Fingerle-Rowson G, Rufibach K, Moore T, Herold M, Hiddemann W. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017 Oct 5;377(14):1331-1344. doi: 10.1056/NEJMoa1614598.

sponsor_collaborators: Institute of Cancer Research, United Kingdom

location_facility: Princess Alexandra Hospital; Department of Haematology

location_facility: National Hospital Organization Kyushu Cancer Center; Hematology

location_facility: A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia

location_facility: Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin

location_facility: Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III

location_facility: National Cancer Center Hospital East;Hematology

location_facility: Aomori Prefectural Central Hospital; Hematology

location_facility: Queen Elizabeth Hospital; Centre for Clinical Haematology

location_facility: Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie

location_facility: Toronto East General Hospital; Haematology/Oncology

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: Castle Hill Hospital; The Queens Centre for Oncology and Haematology

location_facility: Peter MacCallum Cancer Centre; Department of Haematology

location_facility: Ospedale V. Cervello; U.O. Ematologia E Trapianti

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

location_facility: Rambam Medical Center; Heamatology & Bone Marrow Transplantation

location_facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

location_facility: Velindre NHS Trust; Haematology Department

location_facility: University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology

location_facility: Hyogo Cancer Center; Department of hematology

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Hematologia

location_facility: Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch

location_facility: Niigata Cancer Center Hospital; Internal Medicine

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

location_facility: Klinikum der Stadt Ludwigshafen; Medizinische Klinik A

location_facility: National Cancer Center Hospital; Hematology

location_facility: Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia

location_facility: HELIOS Klinikum Erfurt I.Medizinische Klinik

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Nagoya City University Hospital; Hematology and Oncology

location_facility: Institut für Versorgungsforschung in der Onkologie GbR Koblenz

location_facility: Fujian Medical University Union Hospital

location_facility: Kent & Canterbury Hospital; Clinical Haematology

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

location_facility: Semmelweis University, First Dept of Medicine

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie

location_facility: Shikoku Cancer Center; Hematology and Oncology

location_facility: Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: Queen Alexandra Hospital; Haematology and Oncology Centre

location_facility: Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: Aichi Cancer Center Hospital; Hematology and Cell Therapy

location_facility: The Regents of the University of California; Office of Research

location_facility: Fn Hr. Kralove; IV. Interni Hematologicka Klinika

location_facility: Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin

location_facility: Matsushita Memorial Hospital; hematology

location_facility: Southampton General Hospital; Medical Oncology

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Norfolk & Norwich Hospital; Dept of Haematology

location_facility: Kath. Krankenhaus Hagen gem. GmbH, St.-Josefs-Hospital; Klinik für Hämatologie und Onkologie

location_facility: The Jikei University Daisan Hospital; Department of Clinical Oncology and Hematology

location_facility: Tohoku University Hospital; Hematology and Immunology

location_facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

location_facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

location_facility: St.-Antonius-Hospital gGmbH; Klinik für Hämatologie und Onkologie

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: Regional Clinical Hospital N.A. Semashko; Hematology

location_facility: University of Szeged, II Dept of Internal Medicine

location_facility: Leicester Royal Infirmary; Dept of Haematology

location_facility: Concord Repatriation General Hospital; Haematology

location_facility: Chiba Cancer Center;Hematology and Oncology

location_facility: Azienda Ospedaliera Universitaria di Modena

location_facility: The Cancer Institute Hospital of JFCR; Hematology Oncology

location_facility: Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w.

location_facility: Jichi Medical University Hospital; Hematology

location_facility: Aberdeen Royal Infirmary; Haematology - Ward 16

location_facility: Mannheimer Onkologie Praxis Dres. Jürgen Brust Dieter Schuster

location_facility: Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo

location_facility: St James Uni Hospital; Icrf Cancer Medicine Research Unit

location_facility: Royal Cornwall Hospital; Haematology Clinic

location_facility: Fundacion Hospital de Alcorcon; Servicio de Hematologia

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Hopital De La Conception; Hematologie Clinique

location_facility: University Hospital, Kyoto Prefectural University of Medicine; Hematology

location_facility: Universitätsklinikum Jena; Klinik für Innere Medizin II

location_facility: St. Frankziskus Krankenhaus, Med. Klinik I; Klinik für Hämatologie,Onkologie u. Gastroenterologie

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital; Hematology & Oncology

location_facility: Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

location_facility: Royal Bournemouth General Hospital; Haematology

location_facility: James Paget Hospital; Haematology Department

location_facility: Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie

location_facility: Helios Dr. Horst Schmidt Kliniken; Klinik Innere MED III: Hämatologie, Onkologie, Palliativmedizin

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie

location_facility: University of Kansas; Medical Center & Medical pavilion

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I

location_facility: Hiroshima University Hospital; Hematology

location_facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

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

location_facility: Harbin Medical University Cancer Hospital

location_facility: Kobe City Medical Center General Hospital; Hematology

location_facility: Austin and Repatriation Medical Centre; Cancer Services

location_facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

location_facility: Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: Hopital Saint Eloi; Hematologie Oncologie Medicale

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

location_facility: Kumamoto University Hospital; Hematology Rheumatology and Clinical Immunology

location_facility: Republican Clinical Hospital n.a. Baranov; Haematology

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Western General Hospital; Department of Haematology

location_facility: General Hospital of Chinese PLA; Department of Hematology

location_facility: Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

location_facility: Hospital de Basurto; Servicio de Hematologia

location_facility: University College Hospital; Macmillan Cancer Centre

location_facility: Gemeinschaftspraxis Dr. med. Holger Klaproth

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Dr. Georges L. Dumont University Hospital Centre

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II

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

location_facility: Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Universität Tübingen; Med. Klinik; Innere Medizin I

location_facility: UKSH, Campus Kiel; Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie

location_facility: Sahlgrenska Universitetssjukhuset; Sektionen för hematologi och koagulation

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Chaim Sheba Medical Center; Hematology BMT & CBB

title: A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders

location_country:
Finland
Germany
Italy
Hungary
Israel
United Kingdom
Australia
Japan
Sweden
Belgium
United States
China
Spain
Taiwan
Czechia
Canada
Russian Federation
France

collaborators: Institute of Cancer Research, United Kingdom


title: A Phase III, Open-label Study of Once Daily BI 201335 240 mg for 24 Weeks in Combination With Pegylated interferon-a (PegIFN) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN / RBV Treatment

summary: The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.

ReferenceCitation: Foster GR, Ferenci P, Asselah T, Mantry P, Dufour JF, Bourliere M, Forton D, Maevskaya M, Wright D, Yoshida EM, Garcia-Samaniego J, Oliveira C, Wright M, Warner N, Sha N, Quinson AM, Stern JO. Open-label study of faldaprevir plus peginterferon and ribavirin in hepatitis C virus genotype 1-infected patients who failed placebo plus peginterferon and ribavirin. J Viral Hepat. 2016 Mar;23(3):227-31. doi: 10.1111/jvh.12485. Epub 2015 Nov 17.

location_country:
Germany
Portugal
United Kingdom
Romania
Japan
Switzerland
Austria
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Russian Federation
France

location_facility: 1220.48.1009 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8117 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4914 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4906 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0091 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4401 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3204 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1012 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0023 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3509 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0018 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4901 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4404 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8114 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8121 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3301 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4913 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3401 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4002 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4911 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3404 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.7001 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0081 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8201 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0017 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0065 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3503 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3412 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0027 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3203 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8207 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1005 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4302 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8119 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3403 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0078 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4403 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4301 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4408 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0011 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3316 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4106 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.7004 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8106 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3501 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3410 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0058 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3304 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8113 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3311 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0039 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4407 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1016 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3405 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4904 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3402 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4908 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1006 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3312 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0012 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3406 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0095 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1003 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3305 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3502 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0029 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0013 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8802 China Medical University Hospital

location_facility: 1220.48.0004 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0087 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4405 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8204 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0071 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3409 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3201 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3303 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8206 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8118 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8116 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3411 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1007 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8205 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0066 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4409 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0063 Boehringer Ingelheim Investigational Site


title: Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

summary:
A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections. The Pa infection rate in CF patients increases with age and by age 18 years approximately 85% of CF patients in the US are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients.

The purpose of this study is to determine whether Arikayce™ is effective in treating chronic lung infections caused by Pa in CF participants. The effectiveness, safety, and tolerability of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available for use.

ReferenceCitation: Bilton D, Pressler T, Fajac I, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Sole A, Quittner AL, Liu K, McGinnis JP 2nd, Eagle G, Gupta R, Konstan MW; CLEAR-108 Study Group. Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis. J Cyst Fibros. 2020 Mar;19(2):284-291. doi: 10.1016/j.jcf.2019.08.001. Epub 2019 Aug 23.

license: publisher-specific-oa

license_normalized: publisher-specific

lead_sponsor: Insmed Incorporated

location_country:
Germany
Ireland
Italy
Poland
Slovakia
Hungary
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Spain
Greece
Bulgaria
Canada
Serbia
France