Status:
COMPLETED
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT02201901
Start Date
July 1 2014
End Date
November 1 2015
Last Update
November 15 2018
Active Locations (50)
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1
Phoenix, Arizona, United States
2
La Jolla, California, United States
3
Los Angeles, California, United States, 90048
4
Los Angeles, California, United States