search
Back to results

PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)

Primary Purpose

Hepatitis, Hepatitis C, Chronic, Fibrosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PegIntron (peginterferon alfa-2b; SCH 54031)
REBETOL (ribavirin; SCH 18908)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis

Eligibility Criteria

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

Inclusion Criteria: Age at entry 18-65 Positive for Hepatitis C Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis Exclusion Criteria: Any cause for the liver disease other than chronic hepatitis C History or presence of complications of cirrhosis Alcohol or illicit drug use or methadone treatment within the past 2 years Treatment for chronic hepatitis C within the previous 6 months Diseases or conditions that could interfere with the subject's participation in and completion of the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Overall study population

    Arm Description

    Outcomes

    Primary Outcome Measures

    Sustained Virologic Response (SVR) Rate
    Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)

    Secondary Outcome Measures

    Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12
    Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
    Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12
    Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up

    Full Information

    First Posted
    June 13, 2002
    Last Updated
    March 7, 2017
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00039871
    Brief Title
    PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)
    Official Title
    PEG-Intron Plus REBETOL for the Treatment of Subjects With Chronic Hepatitis C Who Failed to Respond to Previous Combination Therapy (Any Alpha Interferon Treatment in Combination With Ribavirin)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2002 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    September 2007 (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 this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    2333 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Overall study population
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    PegIntron (peginterferon alfa-2b; SCH 54031)
    Other Intervention Name(s)
    SCH 54031
    Intervention Description
    PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    REBETOL (ribavirin; SCH 18908)
    Intervention Description
    REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks
    Primary Outcome Measure Information:
    Title
    Sustained Virologic Response (SVR) Rate
    Description
    Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)
    Time Frame
    Assessed at end of 24 weeks posttreatment follow-up
    Secondary Outcome Measure Information:
    Title
    Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12
    Description
    Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
    Time Frame
    24 weeks posttreatment
    Title
    Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12
    Description
    Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
    Time Frame
    24 weeks posttreatment

    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 Positive for Hepatitis C Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis Exclusion Criteria: Any cause for the liver disease other than chronic hepatitis C History or presence of complications of cirrhosis Alcohol or illicit drug use or methadone treatment within the past 2 years Treatment for chronic hepatitis C within the previous 6 months Diseases or conditions that could interfere with the subject's participation in and completion of 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
    21056496
    Citation
    Poynard T, Munteanu M, Colombo M, Bruix J, Schiff E, Terg R, Flamm S, Moreno-Otero R, Carrilho F, Schmidt W, Berg T, McGarrity T, Heathcote EJ, Goncales F, Diago M, Craxi A, Silva M, Boparai N, Griffel L, Burroughs M, Brass C, Albrecht J. FibroTest is an independent predictor of virologic response in chronic hepatitis C patients retreated with pegylated interferon alfa-2b and ribavirin in the EPIC(3) program. J Hepatol. 2011 Feb;54(2):227-35. doi: 10.1016/j.jhep.2010.06.038. Epub 2010 Sep 15. Erratum In: J Hepatol. 2013 Oct;59(4):914.
    Results Reference
    result

    Learn more about this trial

    PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)

    We'll reach out to this number within 24 hrs