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

NCT01045278 | Completed Phase 4

• 1 other identifier: EU-nr 2007-001130-13
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C

Keywords

Hepatitis C patients; Hepacivirus

Outcome Measures

Primary Outcomes (1)

• 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.

  14-72 weeks

Secondary Outcomes (8)

• Prevalence of chronic HCV infection in the patient population eligible for part I in the study.

  Screening visit (first visit of the study).

• Clinical and histological characteristics of chronic hepatitis C.

  Liver investigation visit (second visit of the study). No time frame specified in the protocol.

• Prevalence of hepatic decompensation and cirrhosis/advanced liver disease.

  Liver investigation visit (second visit of the study). No time frame specified in the protocol.

• Risk factors for advanced liver disease.

  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.

  24 weeks post-treatment.

Interventions

Pegylated interferon-alfa-2b and ribavirin DRUG

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
• Written informed consent for part I of the study.
• Fulfilled part I
• Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
• HCV-PCR positive.
• Written informed consent for part II of the study.
• Fulfilled part II
• Registered in a clinic providing maintenance therapy for opiate dependence at the date of study initiation.
• HCV-PCR positive.
• Written informed consent for part III of the study and able to adhere to dosing and visiting schedules.
• At least 6 months of uninterrupted maintenance therapy for opiate dependence.
• Treatment indication with at least one of the following:
• Fibrosis/cirrhosis
• Other HCV related disease/symptoms
• Psychological indication

You may not qualify if:

• The presence of any of the following criteria will exclude the patient from participating in part III of the study:
• Pregnant women, women who plan to become pregnant, male patients whose partner wants to become pregnant, and breastfeeding women.
• Previous treatment for chronic hepatitis C with an antiviral or immunomodulating agent or with an interferon or ribavirin product, whether alone or in combination.
• Participation in another clinical drug trial.
• Coinfection with HBV or HIV
• Hemoglobin \<120 g/L for females and \<130 g/L for males.
• LPK \<3,0 x 109/L
• Platelets \<80 x 109/L
• Creatinin clearance \<50mL/min
• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skåne university hospital

Malmo, Sweden

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Anna Jerkeman, MD

  Skane University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: January 11, 2010
• Study Start: April 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 7, 2013

Record last verified: 2013-10

Locations

SE (1)