A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism

• Status: Unknown status
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with HCV genotype 1 and IL28B CC Polymorphism who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Age > 18 years

• Serum Hepatitis C RNA > 10,000IU/mL

• Hepatitis C virus genotype 1

• IL28B CC polymorphism

Exclusion Criteria:

• Previous treatment for chronic Hepatitis C

• clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml

• HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease

• Contraindications to PR-based treatment:

• Uncontrolled psychiatric illness

• Active substance dependency

• Known autoimmune disorder

• Untreated thyroid disease

• Uncontrolled seizure disorder

• Pregnancy, lactation or inability to maintain contraception

• Chronic kidney disease w/ estimated GFR< 60

• ANC<1.5/nl, Hb<12g/dl, or platelets<75/nl

• Clinical or biochemical evidence of decompensated liver disease including:

• History of encephalopathy

• Ascites

• Variceal bleeding

• Bilirubin > 3g/dl or INR > 1.5

• Life threatening disorder with expected median survival less than 5 years

• Inability to comply with drug regimens or testing schedule required for study