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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01045278
First received: September 11, 2009
Last updated: October 1, 2013
Last verified: October 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Risk factors for advanced liver disease. [ Time Frame: Liver investigation visit (second visit of the study). No time frame specified in the protocol. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • Rates of relapse in opiate drug abuse. [ Time Frame: Treatment period (14-72 weeks) and up till 24 weeks post-treatment. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • Potential pharmacokinetic interactions between ribavirin and methadone or buprenorphine. [ Time Frame: Measured after 4 weeks treatment. ] [ Designated as safety issue: No ]

Enrollment: 277
Study Start Date: April 2008
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pegylated interferon-alfa-2b and ribavirin
    Pegylated interferon-alfa-2b 1.5 microg/kg subcutaneously once weekly plus weight based ribavirin 800-1200 mg PO for a variable period depending on their HCV genotype and response to treatment.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045278

Locations
Sweden
Skåne university hospital
Malmö, Sweden
Sponsors and Collaborators
Region Skane
Investigators
Study Director: Anna Jerkeman, MD Skane University Hospital
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01045278     History of Changes
Other Study ID Numbers: EU-nr 2007-001130-13
Study First Received: September 11, 2009
Last Updated: October 1, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Region Skane:
Hepatitis C patients
Hepacivirus

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

ClinicalTrials.gov processed this record on November 20, 2014