Clinical trial NCT02097966: 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
Overall status: NO_LONGER_AVAILABLE
Conditions: Chronic Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-03-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Local Institution
city: Braunua/Inn
country: Austria
facility: Local Institution
city: Graz
country: Austria
facility: Local Institution
city: Innsbruck
country: Austria
facility: Local Institution
city: Linz
country: Austria
facility: Local Institution
city: Oberndorf
country: Austria
facility: Local Institution
city: Oberpullendorf
country: Austria
facility: Local Institution
city: Salzburg
country: Austria
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Aachen
country: Germany
facility: Local Institution
city: Augsburg
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Bonn
country: Germany
facility: Local Institution
city: Cologne
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Frankfurt Am Main
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Herne
country: Germany
facility: Local Institution
city: Jena
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Leipzig
country: Germany
facility: Local Institution
city: Muenchen
country: Germany
facility: Local Institution
city: Muenster
country: Germany
facility: Local Institution
city: Munchen
country: Germany
facility: Local Institution
city: Stuttgart
country: Germany
facility: Local Institution
city: Tuebingen
country: Germany
facility: Local Institution
city: Ulm
country: Germany
facility: Local Institution
city: Wuerzburg
country: Germany
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Urecht
country: Netherlands
facility: Local Institution
city: Falun
country: Sweden
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Helsingborg
country: Sweden
facility: Local Institution
city: Kalmar
country: Sweden
facility: Local Institution
city: Lulea
country: Sweden
facility: Local Institution
city: Lund
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Sundsvall
country: Sweden
facility: Local Institution
city: Plymouth
country: United Kingdom
facility: Local Institution
state: Devon
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Liverpool
country: United Kingdom
facility: Local Instituition
state: Merseyside
city: Nottingham
country: United Kingdom
facility: Local Institution
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Local Institution
state: Oxfordshire
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution
state: Tyne And Wear
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
city: Leeds
country: United Kingdom
facility: Local Institution
state: Yorkshire
city: Brighton
country: United Kingdom
facility: Local Institution
city: Cardiff
country: United Kingdom
facility: Local Institution
city: Frimley
country: United Kingdom
facility: Local Institution
city: Guildford
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
city: Wrexham
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.
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.