A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection

Completed · Phase 1

Conditions studied: Hepatitis C, Chronic

In brief

A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects with Chronic Hepatitis C Virus Infection.

Key facts

Study ID

NCT01316237

Run by

Gilead Sciences

People needed

90

Starts

2011-01-01

Expected to finish

2012-01-01

Last updated by the study team

2012-03-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subjects (18-60 years of age or up to 64 years of age with approval)
• Documented chronic HCV infection to be of at least 6 months duration and plasma HCV RNA ≥ 5 log10 IU/mL at screening.
• HCV treatment naïve
• Estimated creatinine clearance ≥ 80 mL/min,
• QTcF interval ≤ 450 msec, QRS duration < 100 msec, PR interval < 220 msec,
• Body mass index (BMI) of 19.0 to 34.0 kg/m2, inclusive.
• Eligible subjects must also be HCV treatment-naïve.

You may not qualify if…

• Subjects with prior documentation of cirrhosis, excessive current alcohol intake, any evidence of hepatocellular carcinoma (i.e., α-fetoprotein > 50 ng/mL or by any other standard of care measure)
• Urine drug screen positive for illicit/illegal drugs
• ALT and AST levels > 5 times the upper limit of the normal range (ULN)
• Direct bilirubin > ULN, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets < 100,000/mm3, prothrombin time ≥ 1.5 × ULN and albumin < 3.5 g/dL) are not eligible for study participation.
• Subjects with an absolute neutrophil count (ANC) < 1,000 cells/mm3 (< 750 cells/mm3 for black or African-American subjects), hemoglobin (Hb) < 11 g/dL,
• Coinfected with hepatitis B virus (HBV), human immunodeficiency virus (HIV), or another HCV genotype (other than type 1 for Cohorts 1-5 and type 2 or 3 for Cohort 6) are not eligible for study participation.
• Evidence of hepatocellular carcinoma
• Any sign of decompensated liver disease, including prothrombin time ≥ 1.5 X ULN, platelets < 100,000/mm3 or albumin < 3.5 g/dL at screening OR current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage)
• History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
• History of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility

Where it is running

• Advanced Clinical Research Institute — Anaheim, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• University of Florida - Gainesville — Gainesville, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Saint Louis University — St Louis, Missouri, United States
• CRI Worldwide — Philadelphia, Pennsylvania, United States
• St. Luke Episcopal Hospital — Houston, Texas, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Lifetree Clinical Research, LC — Salt Lake City, Utah, United States
• Charles River Clinical Services Northwest — Tacoma, Washington, United States
• Fundacion De Investigacion De Diego — San Juan, PR, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.