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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B, Chronic

Treatments: Drug: pegylated interferon alpha-2b

Study type: Interventional

Funder types: Industry

Identifiers

NCT00536263

P05170

Details and patient eligibility

About

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.

Enrollment: 671 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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671 participants in 3 patient groups

PEG 1.0 mcg/kg weekly (QW) * 24 weeks

Active Comparator group

Description:

PegIntron 1.0 mcg/kg weekly (QW) \* 24 weeks + 24 weeks follow-up

Treatment:

Drug: pegylated interferon alpha-2b

Drug: pegylated interferon alpha-2b

Drug: pegylated interferon alpha-2b

PEG 1.5 mcg/kg QW * 24 wks

Experimental group

Description:

PegIntron 1.5 mcg/kg QW \* 24 wks + 24 wks follow-up

Treatment:

Drug: pegylated interferon alpha-2b

Drug: pegylated interferon alpha-2b

Drug: pegylated interferon alpha-2b

PEG 1.5 mcg/kg QW * 48 wks

Experimental group

Description:

PegIntron 1.5 mcg/kg QW \* 48 wks + 24 wks follow-up

Treatment:

Drug: pegylated interferon alpha-2b

Drug: pegylated interferon alpha-2b

Drug: pegylated interferon alpha-2b