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Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)

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ClinicalTrials.gov Identifier: NCT00725751
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : April 23, 2012
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date July 25, 2008
First Posted Date July 30, 2008
Results First Submitted Date March 23, 2012
Results First Posted Date April 23, 2012
Last Update Posted Date October 2, 2015
Study Start Date September 2007
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 23, 2012)
Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin [ Time Frame: 24 to 48 weeks ]
For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.
Original Primary Outcome Measures
 (submitted: July 25, 2008)
Proportions of patients with or without substitution therapy who complete treatment with pegylated interferon and ribavirin for hepatitis C and who achieve sustained virologic response (SVR). [ Time Frame: At the end of treatment and 6 months after the end of treatment with pegylated interferon and ribavirin. ]
Change History
Current Secondary Outcome Measures
 (submitted: May 3, 2012)
  • Number of Participants Who Achieved Sustained Virologic Response (SVR) [ Time Frame: 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype) ]
    SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.
  • Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy [ Time Frame: Day 1 ]
    This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.
Original Secondary Outcome Measures
 (submitted: July 25, 2008)
Proportion of patients on substitution therapy within the HCV-infected population who are receiving antiviral treatment. [ Time Frame: At the initiation of treatment with pegylated interferon and ribavirin. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
Official Title Evaluation of Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Patients With/Without Substitution Therapy in Austria
Brief Summary Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients receiving treatment for hepatitis C with/without substitution therapy at sites in Austria.
Condition Hepatitis C, Chronic
Intervention
  • Biological: Pegylated interferon alfa-2b (PegIFN-2b)
    PegIFN-2b administered according to European labeling.
    Other Names:
    • PegIntron
    • SCH 54031
  • Drug: Ribavirin
    Ribavirin administered according to European labeling.
    Other Names:
    • Rebetol
    • SCH 18908
Study Groups/Cohorts
  • PegIFN-2b/ribavirin with substitution therapy
    Participants in this cohort received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
    Interventions:
    • Biological: Pegylated interferon alfa-2b (PegIFN-2b)
    • Drug: Ribavirin
  • PegIFN-2b/ribavirin without substitution therapy
    Participants in this cohort received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
    Interventions:
    • Biological: Pegylated interferon alfa-2b (PegIFN-2b)
    • Drug: Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 23, 2012)
353
Original Estimated Enrollment
 (submitted: July 25, 2008)
37
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients with hepatitis C

Exclusion Criteria:

  • According to the products' European labeling
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Austria
 
Administrative Information
NCT Number NCT00725751
Other Study ID Numbers P05255
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor Merck Sharp & Dohme Corp.
Collaborators Not Provided
Investigators Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2015