A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C

Completed · Phase 1 · Has a placebo group

Conditions studied: Hepatitis C

In brief

Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 and/or days 8-10. Follow-up visits are also required periodically through day 43. Study procedures involve taking blood samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.

Key facts

Study ID

NCT01591668

Run by

Gilead Sciences

People needed

51

Starts

2012-03-01

Expected to finish

2012-12-01

Last updated by the study team

2013-08-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and Females 18-65 years old
• Chronic HCV infection for at least 6 months, treatment naive
• HCV Viral load > 100,000 IU/mL at Screening
• Monoinfection with HCV 1 genotype
• Hepatitis B surface antigen negative
• Screening ECG without clinically significant abnormalities
• BMI 18-33 kg/m\^2
• Creatinine clearing > 70 mL/min
• Negative pregnancy test at screening

You may not qualify if…

• Pregnant or lactating subjects
• Co-infection with hepatitis B virus (HBV) or HIV
• History of Gilberts disease
• Particular abnormal laboratory parameters
• Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
• Evidence of hepatocellular carcinoma
• On-going alcohol abuse
• Positive uring drug screen

Where it is running

• Woodland International Research Group — Little Rock, Arkansas, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Kansas City Gastroenterology and Hepatology — Kansas City, Missouri, United States
• Comprehensive Clinical Research — Berlin, New Jersey, United States
• CRI Worldwide, LLC — Willingboro, New Jersey, United States
• CliniLabs — New York, New York, United States
• CRI Worldwide, LLC — Philadelphia, Pennsylvania, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Lifetree Clinical Research — Salt Lake City, Utah, United States
• Fundacion De Investigacion De Diego — Santurce, PR, Puerto Rico

Full record on ClinicalTrials.gov

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