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

March 9, 2017 updated by: Merck Sharp & Dohme LLC

An Open-label, Randomized Study of PegIntron in the Treatment of HBeAg Positive Chronic Hepatitis B Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

671

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PEG 1.0 mcg/kg weekly (QW) * 24 weeks
PegIntron 1.0 mcg/kg weekly (QW) * 24 weeks + 24 weeks follow-up
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
Experimental: PEG 1.5 mcg/kg QW * 24 wks
PegIntron 1.5 mcg/kg QW * 24 wks + 24 wks follow-up
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
Experimental: PEG 1.5 mcg/kg QW * 48 wks
PegIntron 1.5 mcg/kg QW * 48 wks + 24 wks follow-up
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss
Time Frame: 24 weeks after end of treatment (EOT)
HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)
24 weeks after end of treatment (EOT)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With HBeAg Loss
Time Frame: Up to Treatment Week 48
HBeAg Loss was tested by assay of Abbott MEIA
Up to Treatment Week 48
HBe Seroconversion
Time Frame: End of treatment (EOT) and 24 weeks after EOT
HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA.
End of treatment (EOT) and 24 weeks after EOT
Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL
Time Frame: End of treatment (EOT) and 24 weeks after EOT

HBV-DNA was tested by assay of Roche Cobas Taqman (the test

lowest limit is 6 IU/mL)
End of treatment (EOT) and 24 weeks after EOT
Number of Participants With HBV-DNA < 200 IU/mL
Time Frame: End of treatment (EOT) and 24 weeks after EOT
HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)
End of treatment (EOT) and 24 weeks after EOT
Number of Participants With HBV-DNA Undetectable
Time Frame: End of treatment (EOT) and 24 weeks after EOT
Undetectable HBV-DNA was defined as having a level <6 IU/mL by polymerase chain reaction (PCR).
End of treatment (EOT) and 24 weeks after EOT
Number of Participants With Biochemical Response
Time Frame: End of treatment (EOT) and 24 weeks after EOT
Biochemical response was defined as alanine aminotransferase (ALT) normalization.
End of treatment (EOT) and 24 weeks after EOT
Number of Participants With Combined Response
Time Frame: End of treatment (EOT) and 24 weeks after EOT
Combined response was defined as HBV DNA <20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization
End of treatment (EOT) and 24 weeks after EOT
Hepatitis B Surface Antigen (HBsAg) Loss
Time Frame: End of treatment (EOT) and 24 weeks after EOT
HBsAg Loss was tested by assay of Abbott MEIA
End of treatment (EOT) and 24 weeks after EOT
Hepatitis B Surface Antigen (HBs) Seroconversion
Time Frame: End of treatment (EOT) and 24 weeks after EOT
HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive
End of treatment (EOT) and 24 weeks after EOT
Change From Baseline in Liver Biopsy Score
Time Frame: Baseline to 24 weeks after end of treatment

Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System):

Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis).

Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked [involvement of >2/3 of lobules or nodules]).

Score III (portal inflammation): 0 (none) to 4 (Marked [dense packing of

inflammatory cells in >2/3 of portal tracts]).

Score IV (fibrosis): 0 (none) to 4 (cirrhosis).
Baseline to 24 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 26, 2007

First Submitted That Met QC Criteria

September 26, 2007

First Posted (Estimate)

September 27, 2007

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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