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| Sponsor: | Region Skane |
|---|---|
| Information provided by: | Region Skane |
| ClinicalTrials.gov Identifier: | NCT01045278 |
Purpose
Hepatitis C is the leading cause of chronic liver disease in industrialized countries, and is the most common indication for liver transplantation. In the Western world, the absolute majority of cases of Hepatitis C Virus (HCV) infection are related to the use of injectable narcotic drugs. Most injecting drug users contract HCV infection within the first years after starting injecting drug use. The aim of this study is to study hepatitis C in a cohort of patients registered in clinics providing maintenance therapy for opiate dependence in three metropolitan areas of Sweden. The cohort is defined as all patients registered in these three clinics at the date of study initiation. The study contains four parts:
Part I: the first part of the study aims to evaluate the prevalence of HCV exposure in the cohort and the proportion of anti-HCV positive participants with chronic infection.
Part II: Patients with chronic HCV infection will be offered further investigation of chronic liver disease, including liver biopsy, for selection of candidates for antiviral therapy and identification of risk factors for development of severe liver disease.
Part III: Based on the results of these investigations, patients will be considered for antiviral therapy. Indications for such therapy will mainly be clinical and/or histological signs of chronic liver disease with fibrosis. All patients will receive weight-based doses of pegylated interferon-alfa-2b and ribavirin.
Part IV: Study of pharmacokinetic interactions between ribavirin and opiate substitution molecule (methadone or buprenorphine) in patients receiving antiviral therapy according to part III.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: Pegylated interferon-alfa-2b and ribavirin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hepatitis C in a Cohort of Patients With Maintenance Therapy for Opiate Dependence - Prevalence, Severity and Outcome of Antiviral Therapy |
| Estimated Enrollment: | 450 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients that meet all of the following inclusion criteria are eligible for part I of the study:
Patients that meet all of the following inclusion criteria are eligible for part II of the study:
Patients that meet all of the following inclusion criteria are eligible for part III of the study:
Treatment indication with at least one of the following:
Exclusion Criteria:
The presence of any of the following criteria will exclude the patient from participating in part III of the study:
Any of the following diseases considered to be a dominant cause of the patients chronic liver disease:
Contacts and Locations| Contact: Anna Jerkeman, MD | +46 40 30 10 00 | anna.jerkeman@skane.se |
| Sweden | |
| Malmö University Hospital | Recruiting |
| Malmö, Sweden, 205 02 | |
| Principal Investigator: Anna Jerkeman, MD | |
| Study Director: | Anna Jerkeman, MD | Malmö University Hospital |
More Information
| Responsible Party: | Dept of Infectious Diseases; Malmö University Hospital; Sweden ( Anna Jerkeman ) |
| ClinicalTrials.gov Identifier: | NCT01045278 History of Changes |
| Other Study ID Numbers: | EU-nr 2007-001130-13 |
| Study First Received: | September 11, 2009 |
| Last Updated: | January 8, 2010 |
| Health Authority: | Sweden: Medical Products Agency |
|
Hepatitis C patients Hepacivirus |
|
Hepatitis C Hepatitis Opioid-Related Disorders Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Substance-Related Disorders Disorders of Environmental Origin Mental Disorders Interferon-alpha Interferon Alfa-2a Antiviral Agents |
Interferon Alfa-2b Interferons Ribavirin Peginterferon alfa-2b Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antimetabolites |