EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C
A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C
1 other identifier
expanded_access
N/A
5 countries
56
Brief Summary
The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.
Trial Health
Trial Health Score
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56 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2014
CompletedFirst Posted
Study publicly available on registry
March 27, 2014
CompletedJanuary 27, 2016
November 1, 2015
March 25, 2014
January 26, 2016
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Patients chronically infected with Hepatitis C
- Patients at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options
You may not qualify if:
- Patients who are \<18 years old
- Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF)
- Patients who are pregnant
- Creatinine clearance (CrCl) ≤ 30 mL/min (as estimated by Cockcroft and Gault formula)
- Patients who are pregnant or Women of Child Bearing Potential who are not using required contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Local Institution
Amstetten, Austria
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Braunua/Inn, Austria
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Graz, Austria
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Innsbruck, Austria
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Linz, Austria
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Oberndorf, Austria
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Oberpullendorf, Austria
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Salzburg, Austria
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Vienna, Austria
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Aachen, Germany
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Augsburg, Germany
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Berlin, Germany
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Bonn, Germany
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Cologne, Germany
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Essen, Germany
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Frankfurt, Germany
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Frankfurt am Main, Germany
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Hamburg, Germany
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Hanover, Germany
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Heidelberg, Germany
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Herne, Germany
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Jena, Germany
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Kiel, Germany
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Leipzig, Germany
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München, Germany
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Münster, Germany
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Stuttgart, Germany
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Tübingen, Germany
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Ulm, Germany
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Würzburg, Germany
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Amsterdam, Netherlands
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Rotterdam, Netherlands
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Urecht, Netherlands
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Falun, Sweden
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Gothenburg, Sweden
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Helsingborg, Sweden
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Kalmar, SE-391 85, Sweden
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Luleå, Sweden
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Lund, Sweden
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Stockholm, Sweden
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Sundsvall, Sweden
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Plymouth, Devon, United Kingdom
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London, Greater London, United Kingdom
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Manchester, Greater Manchester, United Kingdom
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Liverpool, Merseyside, L7 8XP, United Kingdom
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Nottingham, Nottinghamshire, United Kingdom
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Oxford, Oxfordshire, United Kingdom
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Newcastle upon Tyne, Tyne and Wear, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Leeds, Yorkshire, United Kingdom
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Brighton, United Kingdom
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Cardiff, United Kingdom
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Frimley, United Kingdom
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Guildford, United Kingdom
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London, United Kingdom
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Wrexham, United Kingdom
Related Publications (2)
Rockstroh JK, Ingiliz P, Petersen J, Peck-Radosavljevic M, Welzel TM, Van der Valk M, Zhao Y, Jimenez-Exposito MJ, Zeuzem S. Daclatasvir plus sofosbuvir, with or without ribavirin, in real-world patients with HIV-HCV coinfection and advanced liver disease. Antivir Ther. 2017;22(3):225-236. doi: 10.3851/IMP3108. Epub 2016 Nov 15.
PMID: 27845298DERIVEDWelzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Wedemeyer H, Berg T, Spengler U, Weiland O, van der Valk M, Rockstroh J, Peck-Radosavljevic M, Zhao Y, Jimenez-Exposito MJ, Zeuzem S. Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort. Gut. 2016 Nov;65(11):1861-1870. doi: 10.1136/gutjnl-2016-312444. Epub 2016 Sep 7.
PMID: 27605539DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb