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Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)

Primary Purpose

Chronic Hepatitis C, Cirrhosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
peginterferon alfa-2b (SCH 54031)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis C; Cirrhosis

Eligibility Criteria

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

Inclusion Criteria: Age at entry 18-65 years; Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin; Liver biopsy demonstrating cirrhosis Exclusion Criteria: Any other cause for liver disease other than chronic hepatitis C; History or presence of complications of cirrhosis; Alcohol or illicit drug abuse or treatment with methadone within the past 2 years; Diseases or conditions that could interfere with participation in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    PegIntron

    Untreated Control

    Arm Description

    PegIntron (peginterferon alfa-2b) 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up

    Outcomes

    Primary Outcome Measures

    Time to Observation of the First Clinical Event Experienced by a Subject
    Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation

    Secondary Outcome Measures

    Time to Observation of the Disease Progression Experienced by a Subject
    Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy.

    Full Information

    First Posted
    November 6, 2002
    Last Updated
    March 7, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00048724
    Brief Title
    Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)
    Official Title
    PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects With Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy With Any Alpha Interferon Plus Ribavirin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2002 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    PegIntron
    Arm Type
    Experimental
    Arm Description
    PegIntron (peginterferon alfa-2b) 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
    Arm Title
    Untreated Control
    Arm Type
    No Intervention
    Intervention Type
    Biological
    Intervention Name(s)
    peginterferon alfa-2b (SCH 54031)
    Other Intervention Name(s)
    PegIntron
    Intervention Description
    0.5 µg/kg subcutaneously once weekly for 60 months
    Primary Outcome Measure Information:
    Title
    Time to Observation of the First Clinical Event Experienced by a Subject
    Description
    Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation
    Time Frame
    Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event
    Secondary Outcome Measure Information:
    Title
    Time to Observation of the Disease Progression Experienced by a Subject
    Description
    Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy.
    Time Frame
    Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event

    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: Age at entry 18-65 years; Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin; Liver biopsy demonstrating cirrhosis Exclusion Criteria: Any other cause for liver disease other than chronic hepatitis C; History or presence of complications of cirrhosis; Alcohol or illicit drug abuse or treatment with methadone within the past 2 years; Diseases or conditions that could interfere with participation in 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
    21419770
    Citation
    Bruix J, Poynard T, Colombo M, Schiff E, Burak K, Heathcote EJ, Berg T, Poo JL, Mello CB, Guenther R, Niederau C, Terg R, Bedossa P, Boparai N, Griffel LH, Burroughs M, Brass CA, Albrecht JK; EPIC3 Study Group. Maintenance therapy with peginterferon alfa-2b does not prevent hepatocellular carcinoma in cirrhotic patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1990-9. doi: 10.1053/j.gastro.2011.03.010. Epub 2011 Mar 17. Erratum In: Gastroenterology. 2013 Oct;145(4):910.
    Results Reference
    derived

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    Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)

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