EXtended Therapy in Hepatitis C Genotype 3 Infected Patients

• Status: Terminated
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of 48 vs 24 weeks of treatment with Peginterferon alfa-2b plus weight-based ribavirin on Sustained Virologic Response (SVR) and relapse rates in patients infected with genotype 3 chronic hepatitis C (CHC) who do not achieve a Rapid Virologic Response (RVR) but attain a complete Early Virologic Response (cEVR).

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

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Schering-Plough
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• Infected with only genotype 3, hepatitis C

• Treatment naïve before current course of therapy

• A positive HCV RNA test result at Week 4 (no RVR)

• A negative HCV RNA test result at Week 12 (cEVR)

• A recent liver biopsy (within 3 years prior to study entry) is required. If the patient has either liver biopsy proven cirrhosis in the past or has splenomegaly with features of cirrhosis on ultrasound and/or thrombocytopenia (<150x109/ml) at any time in the past or has a Fibroscan reading of 10 or above or has a Fibrotest score of 0.75 or above (equivalent to F3 on the METAVIR scale), a biopsy will not be required. A copy of the latest report must be available.

Exclusion Criteria:

• Under age 18

• Co-infection with HIV or Hepatitis B or any other HCV genotype in addition to genotype 3

• Prior treatment for Hepatitis C aside from herbal remedies

• Evidence of decompensated liver disease, such as ascites, bleeding varices, hepatic encephalopathy or jaundice (conjugated hyperbilirubinemia)

• INR > 1.3 at baseline

• Platelet count <70 X 109/μl at baseline

• Those subjects with diabetes and/or systemic hypertension will need to have ocular examinations (as per standard of care [SOC]) prior to treatment and will be excluded if they are found to have a diabetic retinopathy, optic nerve disorders, retinal hemorrhage or any other clinically significant abnormality

• Pre-existing psychiatric conditions including:

• Current moderate or severe depression despite appropriate therapy.

• Active suicidal ideation or previous attempt at suicide

• Patients with a history of severe psychiatric disorder (may be included if so desired by the investigator but pretreatment psychiatric evaluation is required (SOC)).

• Clinical diagnosis of current substance abuse: Alcohol (>40g/d), injection drugs, inhalational drugs (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over the counter drugs within one year of the screening visit.