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

NCT00536263 | Completed Phase 3 Results

• 1 other identifier: P05170
• Study Type: interventional
• Target: 671
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss

  HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)

  24 weeks after end of treatment (EOT)

Secondary Outcomes (10)

• Number of Participants With HBeAg Loss

  Up to Treatment Week 48

• HBe Seroconversion

  End of treatment (EOT) and 24 weeks after EOT

• Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL

  End of treatment (EOT) and 24 weeks after EOT

• Number of Participants With HBV-DNA < 200 IU/mL

  End of treatment (EOT) and 24 weeks after EOT

• Number of Participants With HBV-DNA Undetectable

  End of treatment (EOT) and 24 weeks after EOT

Study Arms (3)

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

ACTIVE COMPARATOR

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

Drug: pegylated interferon alpha-2b

PEG 1.5 mcg/kg QW * 24 wks

EXPERIMENTAL

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

Drug: pegylated interferon alpha-2b

PEG 1.5 mcg/kg QW * 48 wks

EXPERIMENTAL

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

Drug: pegylated interferon alpha-2b

Interventions

pegylated interferon alpha-2b DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 25200354 RESULT

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2007
• First Posted: September 27, 2007
• Study Start: September 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 7, 2017
• Results First Posted: December 21, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share