Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection (ASTRAL-1)

Gilead Sciences

Status and phase

Completed

Phase 3

Conditions

Hepatitis C Virus Infection

Treatments

Drug: Placebo

Drug: SOF/VEL

Study type

Interventional

Funder types

Industry

Identifiers

NCT02201940

GS-US-342-1138

2014-001683-35 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.

Enrollment

741 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing and able to provide written informed consent
HCV RNA ≥ 10^4 IU/mL at screening
HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central laboratory
Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
Classification as treatment naive or treatment experienced
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion criteria

Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
Screening ECG with clinically significant abnormalities
Laboratory results outside of acceptable ranges at Screening
Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)