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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00725751
First received: July 25, 2008
Last updated: October 22, 2013
Last verified: October 2013

July 25, 2008
October 22, 2013
September 2007
March 2011   (final data collection date for primary outcome measure)
Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin [ Time Frame: 24 to 48 weeks ] [ Designated as safety issue: No ]
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.
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. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00725751 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.
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. ] [ Designated as safety issue: No ]
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Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
Evaluation of Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Patients With/Without Substitution Therapy in Austria

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Adult patients receiving treatment for hepatitis C with/without substitution therapy at sites in Austria.

Hepatitis C, Chronic
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
353
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with hepatitis C

Exclusion Criteria:

  • According to the products' European labeling
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00725751
P05255
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP