At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) vs. Interferon Alfa-2B for Treatment of Adult Subjects With Chronic Hepatitis C Not Previously Treated With Interferon: Dose Finding Study
In Brief
A Phase 3 clinical trial evaluating PEG-Intron and Interferon Alfa-2B for Hepatitis C. Completed, enrolled 1,224 participants.
Detailed Summary
This study will determine the efficacy of PEG-Intron (SCH 54031) in participants with chronic Hepatitis C virus (HCV) infection who have not been previously treated with interferon. Participants are randomized to receive one of three doses of PEG-Intron (0.5, 1.0, and 1.5 mg/kg) or Interferon Alfa-2B for 48 weeks. The primary objective of this study is to evaluate the efficacy of PEG-Intron (compared to Interferon Alfa-2B) with respect to response based on loss of detectable HCV ribonucleic acid (HCV-RNA) and normalization of alanine transaminase (ALT) level after 24 weeks of therapy and at 24 weeks of follow-up.
Study Details
Timeline
Interventions
PEG-Intron is administered QW for 48 weeks by SC injection at 0.5, 1.0, and 1.5 mg/kg body weight. Body weight obtained at the baseline visit is used to calculate dosing.
Interferon alfa-2b is administered TIW for 48 weeks by SC injection at 3 MIU regardless of participant body weight.