Trial Search Results

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: LDV/SOF
  • Drug: RBV

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Age ≥ 18, with chronic genotype 1 HCV infection

   - HCV treatment-naive

   - HCV RNA > 10,000 IU/mL at screening

   - Cirrhosis determination; a liver biopsy may be required

   - Screening laboratory values within defined thresholds

   - Use of two effective contraception methods if female of childbearing potential or
   sexually active male

Exclusion Criteria:

   - Pregnant or nursing female or male with pregnant female partner

   - Co-infection with HIV or hepatitis B virus (HBV)

   - Current or prior history of clinical hepatic decompensation

   - Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
   skin cancers)

   - Chronic use of systemic immunosuppressive agents

   - History of clinically significant illness or any other medical disorder that may
   interfere with subject treatment, assessment or compliance with the protocol

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie H. Nguyen, MD
650-498-7878
Recruiting