MedTrace Logo

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

NCT00536263 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 671

Last updated 2017-04-07

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-11-30
Completion
2009-11-30

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536263 on ClinicalTrials.gov