At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years; subjects >65 years must be in generally good health and approved by principal investigator
- ✓Genotype 1 hepatitis C with positive serum HCV-RNA (≥50 IU/mL)
- ✓Liver biopsy within 12 months confirming chronic hepatitis (METAVIR ≥F1)
- ✓Compensated liver disease: hemoglobin ≥9 g/dL, neutrophils ≥0.75×10⁹/L, platelets ≥50×10⁹/L, PT prolongation ≤3 sec, INR ≤1.2, total bilirubin ≤3 mg/dL
- ✕Decompensated cirrhosis
- ✕History of severe psychiatric disease, especially depression
- ✕Current or concurrent malignancies, including hepatocellular carcinoma
- ✕Unstable or significant cardiovascular disease, including clinically significant ECG abnormalities
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of the Sustained Response of Peg-Intron/Ribavirin Combination Therapy in Genotype 1-Infected Hepatitis C Patients for Non-extended Versus 24-week Extended Treatment After 24 Weeks Pilot Treatment in Taiwan
In Brief
A Phase 4 clinical trial evaluating PegIntron (peginterferon alfa-2b; SCH 54031) and Ribavirin for Hepatitis C, Chronic. Completed, enrolled 160 participants.
Detailed Summary
This is an open-label, randomized, comparative, multicenter, 48-week study designed to evaluate the efficacy and safety of combination treatment with pegylated interferon and ribavirin in adult subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C virus (HCV)-ribonucleic acid (RNA) positive) (Genotype 1). All subjects will complete 24 weeks of treatment, termed the Pilot Treatment Program, after which all eligible subjects will be randomly assigned to one of two study groups. One group will be followed for an additional 48 weeks without study medication, while the other will be continuously treated for an additional 24 weeks and then followed for another 24 weeks without study medication. Sustained virologic response, defined as undetectable HCV-RNA in serum at the end of the follow-up period, will be measured along with other outcomes.
Study Details
Timeline
Interventions
Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program
Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program followed by 1.2 to 1.5 microgram/kg weekly for 24 weeks during the extended treatment program
200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program
200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program and for 24 weeks during the extended treatment program