FindTrial
Sign In

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT02097966
Enrollment
Unknown
Registered
2014-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

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.

Interventions

DRUGDaclatasvir
DRUGSofosbuvir
DRUGRibavirin

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion 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

Countries

Austria, Germany, Netherlands, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026