Hepatitis C in a Cohort of Patients With Maintenance Therapy for Opiate Dependence - Prevalence, Severity and Outcome of Antiviral Therapy

October 1, 2013 updated by: Region Skane

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden
        • Skåne University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients that meet all of the following inclusion criteria are eligible for part I of the study:

    1. Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
    2. Written informed consent for part I of the study.

  • Patients that meet all of the following inclusion criteria are eligible for part II of the study:

    1. Fulfilled part I
    2. Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
    3. HCV-PCR positive.
    4. Written informed consent for part II of the study.

  • Patients that meet all of the following inclusion criteria are eligible for part III of the study:

    1. Fulfilled part II
    2. Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
    3. HCV-PCR positive.
    4. Written informed consent for part III of the study and able to adhere to dosing and visiting schedules.
    5. At least 6 months of uninterrupted maintenance therapy for opiate dependence.

    6. Treatment indication with at least one of the following:

      • Fibrosis/cirrhosis
      • Other HCV related disease/symptoms
      • Psychological indication
    7. For patients with cirrhosis, an ultrasound investigation should be performed within six months before study initiation, part III, (not showing signs of HCC).
    8. Use of adequate contraception during the treatment period and for six months after the completion of therapy (for all participants regardless of gender).

Exclusion Criteria:

  • The presence of any of the following criteria will exclude the patient from participating in part III of the study:

    1. Pregnant women, women who plan to become pregnant, male patients whose partner wants to become pregnant, and breastfeeding women.
    2. Previous treatment for chronic hepatitis C with an antiviral or immunomodulating agent or with an interferon or ribavirin product, whether alone or in combination.
    3. Participation in another clinical drug trial.
    4. Coinfection with HBV or HIV
    5. Hemoglobin <120 g/L for females and <130 g/L for males.
    6. LPK <3,0 x 109/L
    7. Platelets <80 x 109/L
    8. Creatinin clearance <50mL/min

    9. Any of the following diseases considered to be a dominant cause of the patients chronic liver disease:

      • Hemochromatosis
      • Alpha-1 antitrypsin deficiency
      • Wilson's disease
      • Autoimmune hepatitis
      • Alcoholic liver disease
      • Non-alcoholic steatohepatitis (NASH)
      • Drug-related liver disease
    10. Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
    11. Patients with organ transplants, except for corneal or hair transplant.
    12. Poorly controlled diabetes mellitus.
    13. Evidence of severe retinopathy or clinically relevant ophthalmological disorder in patients with diabetes mellitus or hypertension.
    14. Poorly controlled epilepsy.
    15. Thyroid dysfunction not adequately controlled
    16. Decompensated cirrhosis (Child-Pugh B-C).
    17. Treatment with immunomodulatory drugs (chronic systemic corticosteroids (equivalent to >10 mg prednisone/day), immunosuppressive drugs, chemotherapy) and/or treatment with herbal drugs for chronic hepatitis.
    18. Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study.

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the completion rates of HCV treatment with pegylated interferon-alfa-2b and ribavirin in patients who are under opiate maintenance treatment and eligible for HCV therapy.
Time Frame: 14-72 weeks
14-72 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of chronic HCV infection in the patient population eligible for part I in the study.
Time Frame: Screening visit (first visit of the study).
Screening visit (first visit of the study).
Clinical and histological characteristics of chronic hepatitis C.
Time Frame: Liver investigation visit (second visit of the study). No time frame specified in the protocol.
Liver investigation visit (second visit of the study). No time frame specified in the protocol.
Prevalence of hepatic decompensation and cirrhosis/advanced liver disease.
Time Frame: Liver investigation visit (second visit of the study). No time frame specified in the protocol.
Liver investigation visit (second visit of the study). No time frame specified in the protocol.
Risk factors for advanced liver disease.
Time Frame: Liver investigation visit (second visit of the study). No time frame specified in the protocol.
Liver investigation visit (second visit of the study). No time frame specified in the protocol.
Proportion of sustained virological responders, defined as a plasma HVC RNA level below Lower Level of Quantification at 24 week post-treatment.
Time Frame: 24 weeks post-treatment.
24 weeks post-treatment.
Rates of relapse in opiate drug abuse.
Time Frame: Treatment period (14-72 weeks) and up till 24 weeks post-treatment.
Treatment period (14-72 weeks) and up till 24 weeks post-treatment.
Prevalence of depressive symptoms and assessment of quality of life before, under and after HCV treatment.
Time Frame: Treatment period (14-72 weeks) and up to 24 weeks post-treatment.
Treatment period (14-72 weeks) and up to 24 weeks post-treatment.
Potential pharmacokinetic interactions between ribavirin and methadone or buprenorphine.
Time Frame: Measured after 4 weeks treatment.
Measured after 4 weeks treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Study Director: Anna Jerkeman, MD, Skåne University Hospital

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

April 1, 2008

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

October 7, 2013

Last Update Submitted That Met QC Criteria

October 1, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EU-nr 2007-001130-13

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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