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

NCT ID: NCT00536263

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 671 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

pegylated interferon alpha-2b

Intervention Type: DRUG

1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks

PEG 1.5 mcg/kg QW * 24 wks

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

Group Type: EXPERIMENTAL

pegylated interferon alpha-2b

Intervention Type: DRUG

1.5 mcg/kg S.C. QW for 24 weeks

PEG 1.5 mcg/kg QW * 48 wks

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

Group Type: EXPERIMENTAL

pegylated interferon alpha-2b

Intervention Type: DRUG

1.5 mcg/kg S.C. QW for 48 weeks

Interventions

pegylated interferon alpha-2b

1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks

Intervention Type: DRUG

pegylated interferon alpha-2b

1.5 mcg/kg S.C. QW for 24 weeks

Intervention Type: DRUG

pegylated interferon alpha-2b

1.5 mcg/kg S.C. QW for 48 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Cheng J, Wang Y, Hou J, Luo D, Xie Q, Ning Q, Ren H, Ding H, Sheng J, Wei L, Chen S, Fan X, Huang W, Pan C, Gao Z, Zhang J, Zhou B, Chen G, Wan M, Tang H, Wang G, Yang Y, Mohamed R, Guan R, Lee TH, Chang WH, Zhenfei H, Ye Z, Xu D. Peginterferon alfa-2b in the treatment of Chinese patients with HBeAg-positive chronic hepatitis B: a randomized trial. J Clin Virol. 2014 Dec;61(4):509-16. doi: 10.1016/j.jcv.2014.08.008. Epub 2014 Aug 18.

Reference Type: RESULT

PMID: 25200354 (View on PubMed)

Other Identifiers

P05170

Identifier Type: -

Identifier Source: org_study_id