A Phase IIa, Double-blind, Randomised, Placebo-Controlled Dose Escalation Study to Evalulate the Safety, Tolerability, Pharmacokinetics and Activity of GS-9450, a Caspase Inhibitor, in Subjects with Chronic Hepatitis C

Phase 1

• Conditions: Chronic Hepatitis C; MedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

• Registration Number: EUCTR2007-001601-16-FR
• Lead Sponsor: Gilead Sciences Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-11
• Study Completion: 2009-03-18
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Adult subjects, ages 18-65 infected with chronic HCV of any genotype who have previously failed treatment with PEG in combination with RIBA.
• Potential subjects must not have hepatic cirrhosis; the absence of cirrhosis must be confirmed by either a liver biopsy performed within one year prior to the screening visit or concordant results from a FibroTest® and a Fibroscan® both performed within one year prior to the screening visit.
• ALT = 1.5 x ULN but < 10 x ULN
• BMI between 19 and 32 kg/m2 (inclusive)
• Creatinine clearance = 70 mL/min
• absolute neutrophil count = 1000/mm3
• hemoglobin = 10 g/dL
• have no clinical or laboratory evidence of hepatic decompensation (i.e., subjects must have platelets = 75,000/mm3, total bilirubin = 1.5 x ULN, prothrombin time = 1.5 x ULN and albumin = 3.0 g/dL).
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

• decompensated liver disease
• evidence of hepatocellular carcinoma (i.e., alpha-fetoprotein 50 ng/mL)
• prior diagnosis of cirrhosis
• positive urine drug screen for opiates, cocaine or amphetamines
• co-infection with hepatitis B virus (HBV)
• human immunodeficiency virus (HIV); pancreatitis
• recent significant infection or symptoms of infection (including mononucleosis or active herpes simplex virus)
• autoimmune disorders
• transplantation
• history of malignancy
• ongoing alcohol abuse (defined as intake of more than 28 units of alcohol per week

Study & Design

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