Phase 3 N=671 Randomized Treatment

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

Hepatitis B, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT00536263 ↗

Enrolled (actual)

671

Serious AEs

5.4%

Results posted

Dec 2010

Primary outcome: Primary: Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss — 39; 40; 70 Participants — p=0.860

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: pegylated interferon alpha-2b (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss	39; 40; 70	0.860
SECONDARY Number of Participants With HBeAg Loss	31; 28; 43	0.700
SECONDARY HBe Seroconversion	31; 27; 40; 38; 36; 67	0.598
SECONDARY Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL	46; 61; 76; 44; 47; 75	0.076
SECONDARY Number of Participants With HBV-DNA < 200 IU/mL	10; 14; 21; 12; 12; 22	0.373
SECONDARY Number of Participants With HBV-DNA Undetectable	4; 3; 8; 4; 3; 8	0.724
SECONDARY Number of Participants With Biochemical Response	75; 86; 103; 63; 80; 103	0.219
SECONDARY Number of Participants With Combined Response	11; 11; 23; 18; 23; 45	0.995
SECONDARY Hepatitis B Surface Antigen (HBsAg) Loss	1; 1; 4; 1; 1; 4	0.991
SECONDARY Hepatitis B Surface Antigen (HBs) Seroconversion	0; 0; 1; 0; 0; 2	0.991
SECONDARY Change From Baseline in Liver Biopsy Score	8.0; 8.4; 8.2; -1.1; -1.7; -1.6	0.014 sig

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.

Eligibility Criteria

Inclusion Criteria

Adults with chronic hepatitis B:
Serum hepatitis B surface antigen positive for at least 6 months
Serum hepatitis B e antigen positive
Serum negative for hepatitis B surface and e antibodies
Plasma hepatitis B virus deoxyribonucleic acid (DNA) level greater than 20,000 IU/mL
Alanine aminotransferase (ALT) 2- to 10-times the upper limit of normal
Compensated liver disease with certain minimum hematological and serum biochemical criteria

Exclusion Criteria

Significant hepatic disease from an etiology other than hepatitis B virus
Antiviral treatment for hepatitis within previous 6 months
History of severe psychiatric disease, especially depression
Unstable or significant cardiovascular disease
Prolonged exposure to known hepatotoxins such as alcohol or drugs
Any condition that could interfere with the subject participating in and completing the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00536263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.