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

January 26, 2016 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Amstetten, Austria
        • Local Institution
      • Braunua/Inn, Austria
        • Local Institution
      • Graz, Austria
        • Local Institution
      • Innsbruck, Austria
        • Local Institution
      • Linz, Austria
        • Local Institution
      • Oberndorf, Austria
        • Local Institution
      • Oberpullendorf, Austria
        • Local Institution
      • Salzburg, Austria
        • Local Institution
      • Vienna, Austria
        • Local Institution
      • Wien, Austria
        • Local Institution
  • Germany
      • Aachen, Germany
        • Local Institution
      • Augsburg, Germany
        • Local Institution
      • Berlin, Germany
        • Local Institution
      • Bonn, Germany
        • Local Institution
      • Cologne, Germany
        • Local Institution
      • Essen, Germany
        • Local Institution
      • Frankfurt, Germany
        • Local Institution
      • Frankfurt Am Main, Germany
        • Local Institution
      • Hamburg, Germany
        • Local Institution
      • Hannover, Germany
        • Local Institution
      • Heidelberg, Germany
        • Local Institution
      • Herne, Germany
        • Local Institution
      • Jena, Germany
        • Local Institution
      • Kiel, Germany
        • Local Institution
      • Leipzig, Germany
        • Local Institution
      • Muenchen, Germany
        • Local Institution
      • Muenster, Germany
        • Local Institution
      • Munchen, Germany
        • Local Institution
      • Stuttgart, Germany
        • Local Institution
      • Tuebingen, Germany
        • Local Institution
      • Ulm, Germany
        • Local Institution
      • Wuerzburg, Germany
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands
        • Local Institution
      • Rotterdam, Netherlands
        • Local Institution
      • Urecht, Netherlands
        • Local Institution
  • Sweden
      • Falun, Sweden
        • Local Institution
      • Gothenburg, Sweden
        • Local Institution
      • Helsingborg, Sweden
        • Local Institution
      • Kalmar, Sweden, SE-391 85
        • Local Institution
      • Lulea, Sweden
        • Local Institution
      • Lund, Sweden
        • Local Institution
      • Stockholm, Sweden
        • Local Institution
      • Sundsvall, Sweden
        • Local Institution
  • United Kingdom
      • Brighton, United Kingdom
        • Local Institution
      • Cardiff, United Kingdom
        • Local Institution
      • Frimley, United Kingdom
        • Local Institution
      • Guildford, United Kingdom
        • Local Institution
      • London, United Kingdom
        • Local Institution
      • Wrexham, United Kingdom
        • Local Institution
    • Devon
      • Plymouth, Devon, United Kingdom
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom
        • Local Institution
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
        • Local Instituition
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom
        • Local Institution
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom
        • Local Institution
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom
        • Local Institution
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
        • Local Institution
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI444-237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Hepatitis C

Clinical Trials on Sofosbuvir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe