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
Primary Purpose
Chronic Hepatitis C
Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Daclatasvir
Sofosbuvir
Ribavirin
Sponsored by
About this trial
This is an expanded access trial for Chronic Hepatitis C
Eligibility Criteria
This program is conducted in the EU (Germany, Austria, Norway, The Netherlands, Sweden and United Kingdom only)
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Local Institution
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Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02097966
Brief Title
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
Official Title
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
Study Type
Expanded Access
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Other Intervention Name(s)
BMS-790052
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Intervention Type
Drug
Intervention Name(s)
Ribavirin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
This program is conducted in the EU (Germany, Austria, Norway, The Netherlands, Sweden and United Kingdom only)
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Amstetten
Country
Austria
Facility Name
Local Institution
City
Braunua/Inn
Country
Austria
Facility Name
Local Institution
City
Graz
Country
Austria
Facility Name
Local Institution
City
Innsbruck
Country
Austria
Facility Name
Local Institution
City
Linz
Country
Austria
Facility Name
Local Institution
City
Oberndorf
Country
Austria
Facility Name
Local Institution
City
Oberpullendorf
Country
Austria
Facility Name
Local Institution
City
Salzburg
Country
Austria
Facility Name
Local Institution
City
Vienna
Country
Austria
Facility Name
Local Institution
City
Wien
Country
Austria
Facility Name
Local Institution
City
Aachen
Country
Germany
Facility Name
Local Institution
City
Augsburg
Country
Germany
Facility Name
Local Institution
City
Berlin
Country
Germany
Facility Name
Local Institution
City
Bonn
Country
Germany
Facility Name
Local Institution
City
Cologne
Country
Germany
Facility Name
Local Institution
City
Essen
Country
Germany
Facility Name
Local Institution
City
Frankfurt Am Main
Country
Germany
Facility Name
Local Institution
City
Frankfurt
Country
Germany
Facility Name
Local Institution
City
Hamburg
Country
Germany
Facility Name
Local Institution
City
Hannover
Country
Germany
Facility Name
Local Institution
City
Heidelberg
Country
Germany
Facility Name
Local Institution
City
Herne
Country
Germany
Facility Name
Local Institution
City
Jena
Country
Germany
Facility Name
Local Institution
City
Kiel
Country
Germany
Facility Name
Local Institution
City
Leipzig
Country
Germany
Facility Name
Local Institution
City
Muenchen
Country
Germany
Facility Name
Local Institution
City
Muenster
Country
Germany
Facility Name
Local Institution
City
Munchen
Country
Germany
Facility Name
Local Institution
City
Stuttgart
Country
Germany
Facility Name
Local Institution
City
Tuebingen
Country
Germany
Facility Name
Local Institution
City
Ulm
Country
Germany
Facility Name
Local Institution
City
Wuerzburg
Country
Germany
Facility Name
Local Institution
City
Amsterdam
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
Country
Netherlands
Facility Name
Local Institution
City
Urecht
Country
Netherlands
Facility Name
Local Institution
City
Falun
Country
Sweden
Facility Name
Local Institution
City
Gothenburg
Country
Sweden
Facility Name
Local Institution
City
Helsingborg
Country
Sweden
Facility Name
Local Institution
City
Kalmar
ZIP/Postal Code
SE-391 85
Country
Sweden
Facility Name
Local Institution
City
Lulea
Country
Sweden
Facility Name
Local Institution
City
Lund
Country
Sweden
Facility Name
Local Institution
City
Stockholm
Country
Sweden
Facility Name
Local Institution
City
Sundsvall
Country
Sweden
Facility Name
Local Institution
City
Plymouth
State/Province
Devon
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
State/Province
Greater Manchester
Country
United Kingdom
Facility Name
Local Instituition
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Local Institution
City
Nottingham
State/Province
Nottinghamshire
Country
United Kingdom
Facility Name
Local Institution
City
Oxford
State/Province
Oxfordshire
Country
United Kingdom
Facility Name
Local Institution
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
Country
United Kingdom
Facility Name
Local Institution
City
Leeds
State/Province
Yorkshire
Country
United Kingdom
Facility Name
Local Institution
City
Brighton
Country
United Kingdom
Facility Name
Local Institution
City
Cardiff
Country
United Kingdom
Facility Name
Local Institution
City
Frimley
Country
United Kingdom
Facility Name
Local Institution
City
Guildford
Country
United Kingdom
Facility Name
Local Institution
City
London
Country
United Kingdom
Facility Name
Local Institution
City
Wrexham
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27845298
Citation
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.
Results Reference
derived
PubMed Identifier
27605539
Citation
Welzel 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. Erratum In: Gut. 2016 Dec;65(12 ):2060.
Results Reference
derived
Links:
URL
http://www.bms.com/clinical_trials/investigator_sponsored_research/Pages/expanded-access-program.aspx
Description
EAP Investigator Requests
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
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
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