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

Bristol-Myers Squibb (BMS)

Status

Conditions: Chronic Hepatitis C

Treatments: Drug: Ribavirin; Drug: Sofosbuvir; Drug: Daclatasvir

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02097966

AI444-237

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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