Trial Search Results

Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Intervention(s):

  • Drug: LDV/SOF
  • Drug: RBV

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Age ≥ 18 years, with chronic genotype 1 HCV infection

   - HCV RNA equal to or greater than 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

   - 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

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie H Nguyen
650-498-7878
Not Recruiting