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Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)

Primary Purpose

Hepatitis C, Chronic, Hepatitis C

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PegIntron (peginterferon alfa-2b)
PegIntron (peginterferon alfa-2b)
PegIntron (peginterferon alfa-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 C, Chronic focused on measuring alanine transaminase

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with chronic hepatitis C patients (CHC) who met all of the following criteria:

  • At least 20 years of age and willing to sign an informed consent
  • Patients who can practice contraception
  • Patients who are classified either as relapsers or non-responders.
  • Weight between 45 and 100 kg
  • Patients willing to be hospitalized for 3 days after the start of treatment
  • Patients with positive HCV-RNA
  • Serum ALT level: Over 60 IU/L, equal to or less than 150 IU/L
  • Neutrophil count: equal to or more than 1,200 /mm^3
  • Platelet count：equal to or more than 100,000/mm^3

Exclusion Criteria:

  • Patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    0.25 Dose Group

    0.5 Dose Group

    1.0 Dose Group

    No-treatment Control

    Arm Description

    PegIntron 0.25 mcg/kg SC QW for 12 weeks

    PegIntron 0.5 mcg/kg SC QW for 12 weeks

    PegIntron 1.0 mcg/kg SC QW for 12 weeks

    No treatment (no placebo)

    Outcomes

    Primary Outcome Measures

    Percentage of patients who achieve normalization of ALT in each treatment group

    Secondary Outcome Measures

    Safety: adverse events, adverse reactions, laboratory test result (hematology, blood biochemistry and thyroid function test)

    Full Information

    First Posted
    November 6, 2008
    Last Updated
    March 8, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00787371
    Brief Title
    Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)
    Official Title
    Study to Confirm Dose Response With PegIntron (SCH 54031) Monotherapy in Patients With Chronic Hepatitis C
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 2006 (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
    In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore, the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW) PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese patients with chronic hepatitis C.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, Chronic, Hepatitis C
    Keywords
    alanine transaminase

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    69 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    0.25 Dose Group
    Arm Type
    Experimental
    Arm Description
    PegIntron 0.25 mcg/kg SC QW for 12 weeks
    Arm Title
    0.5 Dose Group
    Arm Type
    Experimental
    Arm Description
    PegIntron 0.5 mcg/kg SC QW for 12 weeks
    Arm Title
    1.0 Dose Group
    Arm Type
    Experimental
    Arm Description
    PegIntron 1.0 mcg/kg SC QW for 12 weeks
    Arm Title
    No-treatment Control
    Arm Type
    No Intervention
    Arm Description
    No treatment (no placebo)
    Intervention Type
    Biological
    Intervention Name(s)
    PegIntron (peginterferon alfa-2b)
    Other Intervention Name(s)
    PegIntron, peginterferon alfa-2b, SCH 54031
    Intervention Description
    PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
    Intervention Type
    Biological
    Intervention Name(s)
    PegIntron (peginterferon alfa-2b)
    Other Intervention Name(s)
    PegIntron, peginterferon alfa-2b, SCH 54031
    Intervention Description
    PegIntron 0.5 mcg/kg SC QW for 12 weeks
    Intervention Type
    Biological
    Intervention Name(s)
    PegIntron (peginterferon alfa-2b)
    Other Intervention Name(s)
    PegIntron, peginterferon alfa-2b, SCH 54031
    Intervention Description
    PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
    Primary Outcome Measure Information:
    Title
    Percentage of patients who achieve normalization of ALT in each treatment group
    Time Frame
    Measured at the end of 12 weeks of treatment or at discontinuation.
    Secondary Outcome Measure Information:
    Title
    Safety: adverse events, adverse reactions, laboratory test result (hematology, blood biochemistry and thyroid function test)
    Time Frame
    Measured between when the patient signs the informed consent form and the end of post-treatment follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with chronic hepatitis C patients (CHC) who met all of the following criteria: At least 20 years of age and willing to sign an informed consent Patients who can practice contraception Patients who are classified either as relapsers or non-responders. Weight between 45 and 100 kg Patients willing to be hospitalized for 3 days after the start of treatment Patients with positive HCV-RNA Serum ALT level: Over 60 IU/L, equal to or less than 150 IU/L Neutrophil count: equal to or more than 1,200 /mm^3 Platelet count：equal to or more than 100,000/mm^3 Exclusion Criteria: Patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.

    12. IPD Sharing Statement

    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)

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