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.
Drug: GS-6620 tablet, 450 mg BID
Drug: GS-6620 tablet
Drug: GS-6620 tablet
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Locations near you
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Full eligibility criteria for NCT01316237
Ages eligible for Study
18 Years to 60 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
Body mass index (BMI) of 19.0 to 34.0 kg/m2, inclusive.
Eligible subjects must also be HCV treatment-naïve.
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
All locations for NCT01316237
United States (12)
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Axis Clinical Trials
Los Angeles, California, United States, 90057
Avail Clinical Research, LLC
Deland, Florida, United States, 32720
University of Florida - Gainesville
Gainesville, Florida, United States, 32608
Orlando, Florida, United States, 32803
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Saint Louis University
St. Louis, Missouri, United States, 63104
Philadelphia, Pennsylvania, United States, 19139
Houston, Texas, United States, 77030
Alamo Medical Research
San Antonio, Texas, United States, 78215
Lifetree Clinical Research, LC
Salt Lake City, Utah, United States, 84106
Charles River Clinical Services Northwest
Tacoma, Washington, United States, 98418
Puerto Rico (1)
Fundacion De Investigacion De Diego
Puerto Rico, Puerto Rico, 00927
View full eligibility
Tris trial is registered with FDA with number: NCT01316237. The sponsor of the trial is Gilead Sciences and it is looking for 90 volunteers for the current phase.
Official trial title: A Phase 1 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
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