Status:
COMPLETED
A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
Lead Sponsor:
Gilead Sciences
Conditions:
HCV Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C ...
Eligibility Criteria
Inclusion
- Chronically infected with HCV genotype 1
- HCV treatment-naïve
- Not co-infected with HIV or HBV
- HCV RNA viral load of at least 100,000 IU/mL
- BMI 19 to 35 kg/m2
- Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
Exclusion
- History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- Decompensated liver disease or cirrhosis or evidence of hepatocellular carcinoma
- Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
- Subjects with known, current use of amphetamines and/or cocaine; subjects taking methadone or buprenorphine (opioid replacement therapy) or ongoing alcohol abuse
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01193478
Start Date
August 1 2010
End Date
December 1 2011
Last Update
January 21 2013
Active Locations (13)
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1
Anaheim, California, United States, 92801
2
Cypress, California, United States, 90630
3
National City, California, United States, 91950
4
Washington D.C., District of Columbia, United States, 20010