Study to evaluate different duration of treatment regimes of 40kD pegylated interferon alfa 2a (Pegasys) plus ribavirin on sustained virological responses (SVR) in Genotype 3 HCV infected cirrhotic patients - STEPS in Geno 3 Cirrhotics

Phase 1

• Conditions: Chronic hepatitis C infection with genotype 3 and advanced fibrosis; MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C

• Registration Number: EUCTR2007-002743-24-GB
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-25
• Study Completion: 2012-08-17
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Chronic genotype 3 HCV infection as evidenced by HCV antibody and RNA positivity with genotype 3 infection confirmed at a central laboratory.

Liver biopsy within 18 months of entry showing features of chronic HCV infection and modified Ishak fibrosis score of equal to or greater than 4 OR radiological and/or endoscopic features of cirrhosis.

HBsAg negative,

No clinical evidence of co-infection with HIV

Platelet count =30,000 cells/mm3, Neutrophil count > 600 cells/mm3

Compensated liver disease (Child-Pugh Grade A clinical classification – Appendix 2)

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

Previous therapy for chronic HCV infection -interferon alpha (IFN), PEG-IFN, ribavirin, viramidine, levovirin, or investigational HCV protease or polymerase inhibitors

Patients who are expected to need alternative antiviral therapy with established or perceived activity against HCV at any time during their participation in the study are also excluded

Evidence of other cause of significant liver disease – serum ferritin > 1000, biochemical evidence of Wilson’s disease, autoantibody titres in excess of 1:160

Platelet count < 30,000 cells/mm3, Neutrophil count = 600 cells/mm3

Poorly controlled diabetes that, in the opinion of the investigator, precludes therapy

Severe retinopathy that, in the opinion of the investigator, precludes therapy

Decompensated cirrhosis (Childs Pugh B or C)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Determine whether reduction of the amount of hepatitis C virus in the blood (HCV viral load) at weeks 4 and 12 on either arm is predictive of final outcome. Current daat suggests that this maybe the case in all types of Hepatitis C infection.;Primary end point(s): Proportion of patients with undetectable virus 6 months after completion of medication.;Main Objective: To compare the efficacy and safety of once weekly (qw) Pegasys 180µg in combination with daily Copegus (800mg) for 24 weeks with the efficacy and safety of 180µg dosing of Pegasys with Copegus (800mg) FOR 48 weeks in Genotype 3 HCV infected individuals with liver cirrhosis.