- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00725751
Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
October 1, 2015 updated by: Merck Sharp & Dohme LLC
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
353
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients receiving treatment for hepatitis C with/without substitution therapy at sites in Austria.
Description
Inclusion Criteria:
- Adult patients with hepatitis C
Exclusion Criteria:
- According to the products' European labeling
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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)
|
PegIFN-2b administered according to European labeling.
Other Names:
Ribavirin administered according to European labeling.
Other Names:
|
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)
|
PegIFN-2b administered according to European labeling.
Other Names:
Ribavirin administered according to European labeling.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 to 48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)
|
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.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
July 25, 2008
First Submitted That Met QC Criteria
July 25, 2008
First Posted (Estimate)
July 30, 2008
Study Record Updates
Last Update Posted (Estimate)
October 2, 2015
Last Update Submitted That Met QC Criteria
October 1, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Ribavirin
- Interferon alpha-2
- Peginterferon alfa-2b
Other Study ID Numbers
- P05255
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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