Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-9857 in Subjects With Chronic Hepatitis C Virus Infection
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Hepatitis, Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | June 2014 |
End Date: | September 2015 |
Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-9857 in Subjects With Chronic Hepatitis C Virus Infection
This study will evaluate the safety, tolerability, and antiviral activity of GS-9857 alone
or with sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) in adults with genotypes 1, 2,
3, or 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48
weeks after the last dose to monitor for persistence of viral mutations.
or with sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) in adults with genotypes 1, 2,
3, or 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48
weeks after the last dose to monitor for persistence of viral mutations.
Inclusion Criteria:
- Chronic genotype 1-4 HCV infection
- For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for
Cohort 10)
- 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
- Presence of cirrhosis
- Prior exposure to approved or experimental HCV Protease Inhibitors
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- 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
We found this trial at
11
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials