A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Multiple Doses of ACH-0137171 in Subjects with Chronic Hepatitis C Infectio

• Conditions: Chronic Hepatitis C Infection; MedDRA version: 8.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

• Registration Number: EUCTR2006-002696-40-DE
• Lead Sponsor: Achillion Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Chronic HCV infection must be documented by positive anti HCV antibody using a third generation enzyme immunoassay (EIA) and persistent detection of HCV RNA in the blood for at least 6 months. Subjects must be infected with HCV genotype 1 (line probe assay; INNO-LiPA HCV II, Innogenetics) and may be treatment-naïve or treatment-experienced (treatment experience specifically means prior interferon, standard or pegylated, with or without ribavirin with therapy stopped > 6 months prior to screening). In addition, eligible subjects must have ALT and AST = 5 x upper limit of normal (ULN), plasma HCV RNA = 5 log10 IU/mL, and have no clinical or laboratory evidence of hepatic decompensation for inclusion (must have platelets >100,000/mm3, total bilirubin = 1.5 x ULN, prothrombin time = 1.5 x ULN, or albumin = 3.0 g/dL for inclusion). Women are eligible if not pregnant or breast-feeding. Women of childbearing potential (i.e., not surgically sterile or confirmed post menopausal) must have confirmed negative pregnancy tests. All subjects must practice a medically acceptable form of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects are not eligible for the following reasons: HIV or HBV co-infection, known cirrhosis, prior history of clinical hepatic decompensation (ascites, jaundice, encephalopathy or variceal hemorrhage), alcoholic or other forms of chronic liver disease, evidence of hepatocellular carcinoma (alpha-fetoprotein > 50 ng/mL), creatinine clearance = 80 mL/min (using Cockcroft-Gault equation), hemoglobin < 10 g/dL, neutrophils < 1500/mm3, abnormal thyroid function tests (TSH > 2.5 µIU/mL, free T4 > ULN), or, a positive test result for illicit drugs, alcohol, or, drug abuse within the past 12 months. Subjects who have significant gastrointestinal, thyroid, renal, cardiovascular, pulmonary, oncologic, or neurological disease, or who are currently receiving immunomodulators (corticosteroids, etc), investigational, nephrotoxic or hepatotoxic drugs will also be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified