NCT00536263

PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)

An Open-label, Randomized Study of PegIntron in the Treatment of HBeAg Positive Chronic Hepatitis B Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 671 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks after their treatment ends.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	pegylated interferon alpha-2b	1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks
DRUG	pegylated interferon alpha-2b	1.5 mcg/kg S.C. QW for 24 weeks
DRUG	pegylated interferon alpha-2b	1.5 mcg/kg S.C. QW for 48 weeks

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2007-09-27
• Last updated: 2017-04-07
• Results posted: 2010-12-21