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

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
pegylated interferon alpha-2b
pegylated interferon alpha-2b
pegylated interferon alpha-2b
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

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

    PEG 1.5 mcg/kg QW * 24 wks

    PEG 1.5 mcg/kg QW * 48 wks

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss
    HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 26, 2007
    Last Updated
    March 9, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00536263
    Brief Title
    PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
    Official Title
    An Open-label, Randomized Study of PegIntron in the Treatment of HBeAg Positive Chronic Hepatitis B Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    671 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PEG 1.0 mcg/kg weekly (QW) * 24 weeks
    Arm Type
    Active Comparator
    Arm Description
    PegIntron 1.0 mcg/kg weekly (QW) * 24 weeks + 24 weeks follow-up
    Arm Title
    PEG 1.5 mcg/kg QW * 24 wks
    Arm Type
    Experimental
    Arm Description
    PegIntron 1.5 mcg/kg QW * 24 wks + 24 wks follow-up
    Arm Title
    PEG 1.5 mcg/kg QW * 48 wks
    Arm Type
    Experimental
    Arm Description
    PegIntron 1.5 mcg/kg QW * 48 wks + 24 wks follow-up
    Intervention Type
    Drug
    Intervention Name(s)
    pegylated interferon alpha-2b
    Intervention Description
    1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    pegylated interferon alpha-2b
    Intervention Description
    1.5 mcg/kg S.C. QW for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    pegylated interferon alpha-2b
    Intervention Description
    1.5 mcg/kg S.C. QW for 48 weeks
    Primary Outcome Measure Information:
    Title
    Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss
    Description
    HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)
    Time Frame
    24 weeks after end of treatment (EOT)
    Secondary Outcome Measure Information:
    Title
    Number of Participants With HBeAg Loss
    Description
    HBeAg Loss was tested by assay of Abbott MEIA
    Time Frame
    Up to Treatment Week 48
    Title
    HBe Seroconversion
    Description
    HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA.
    Time Frame
    End of treatment (EOT) and 24 weeks after EOT
    Title
    Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL
    Description
    HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)
    Time Frame
    End of treatment (EOT) and 24 weeks after EOT
    Title
    Number of Participants With HBV-DNA < 200 IU/mL
    Description
    HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)
    Time Frame
    End of treatment (EOT) and 24 weeks after EOT
    Title
    Number of Participants With HBV-DNA Undetectable
    Description
    Undetectable HBV-DNA was defined as having a level <6 IU/mL by polymerase chain reaction (PCR).
    Time Frame
    End of treatment (EOT) and 24 weeks after EOT
    Title
    Number of Participants With Biochemical Response
    Description
    Biochemical response was defined as alanine aminotransferase (ALT) normalization.
    Time Frame
    End of treatment (EOT) and 24 weeks after EOT
    Title
    Number of Participants With Combined Response
    Description
    Combined response was defined as HBV DNA <20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization
    Time Frame
    End of treatment (EOT) and 24 weeks after EOT
    Title
    Hepatitis B Surface Antigen (HBsAg) Loss
    Description
    HBsAg Loss was tested by assay of Abbott MEIA
    Time Frame
    End of treatment (EOT) and 24 weeks after EOT
    Title
    Hepatitis B Surface Antigen (HBs) Seroconversion
    Description
    HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive
    Time Frame
    End of treatment (EOT) and 24 weeks after EOT
    Title
    Change From Baseline in Liver Biopsy Score
    Description
    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).
    Time Frame
    Baseline to 24 weeks after end of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    25200354
    Citation
    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.
    Results Reference
    result

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

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