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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):

Study Description
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).

Condition or disease Intervention/treatment
Hepatitis C, Chronic Biological: Pegylated interferon alfa-2b (PegIFN-2b) Drug: Ribavirin

Study Design

Study Type : Observational
Actual Enrollment : 353 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Patients With/Without Substitution Therapy in Austria
Study Start Date : September 2007
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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)
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 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)
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients receiving treatment for hepatitis C with/without substitution therapy at sites in Austria.
Criteria

Inclusion Criteria:

  • Adult patients with hepatitis C

Exclusion Criteria:

  • According to the products' European labeling
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725751     History of Changes
Other Study ID Numbers: P05255
First Posted: July 30, 2008    Key Record Dates
Results First Posted: April 23, 2012
Last Update Posted: October 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs