Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir

Criteria

Inclusion Criteria:

• Willing and able to provide written informed consent

• HCV RNA > 10^4 IU/mL at screening

• Chronic HCV infection (≥ 6 months)

• Confirmed CPT class B (7-9) at screening

Exclusion Criteria:

• Current or prior history of solid organ transplantation, significant pulmonary disease, significant cardiac disease, or porphyria

• Inability to exclude hepatocellular carcinoma (HCC) by imaging within 6 months of baseline/Day 1

• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

• Screening ECG with clinically significant abnormalities

• Prior exposure to SOF or any other nucleotide analogue HCV nonstructural protein 5B (NS5B) inhibitor or any HCV NS5A inhibitor

• Laboratory results outside of acceptable ranges at screening