Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

Completed · Phase 2

Conditions studied: Chronic HCV Infection

In brief

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.

Key facts

Study ID

NCT02120300

Run by

Gilead Sciences

People needed

122

Starts

2014-04-01

Expected to finish

2015-08-01

Last updated by the study team

2016-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hemophilia A, B or C, or Von Willebrand's disease
• Chronic genotype 1, 2, 3 or 4 HCV infection
• HCV RNA ≥ 1000 IU/mL at screening
• Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male
• Screening laboratory values within defined thresholds
• For HIV-1/HCV co-infected individuals:
• Suppressed HIV-1 RNA on an antiretroviral (ARV) regimen for at least 6 months prior to screening
• Stable protocol-approved ARV regimen for > 8 weeks prior to screening
• CD4 T-cell count > 200 cells/mm\^3 at screening

You may not qualify if…

• Clinically-significant illness (other than HCV, inherited bleeding disorder or HIV-1) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
• Current or prior history of any of the following:
• Hepatic decompensation
• Chronic liver disease of a non-HCV etiology
• Hepatocellular carcinoma (HCC)
• Infection with hepatitis B virus (HBV)
• Pregnant or nursing female
• Prior treatment with inhibitors of nonstructural protein 5A (NS5A) or the NS5B polymerase
• Chronic use of systemically administered immunosuppressive agents
• For HIV-1/HCV co-infected individuals:
• Opportunistic infection within 6 months prior to screening
• Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline

Where it is running

• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Newark, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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