HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group.

This study has been completed.
Sponsor:
Information provided by:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00147784
First received: September 6, 2005
Last updated: March 26, 2008
Last verified: March 2008
  Purpose
  • To evaluate if weekly psychological follow-up make opioid dependent patients in MMT able to accomplish 14 weeks treatment with Peginterferon alfa-2a (PEG-INF) and ribavirin to the same extent than non-opioid dependents.
  • To determine the efficacy of this anti-HCV treatment

Condition Intervention Phase
Opiate Dependence
Hepatitis
Drug: Ribavirin
Drug: Pegylated Interferon
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a Methadone Maintenance Treated (MMT) Opioid Addicted Group.

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • - Percent of patients with sustained virological response, defined as undetectable HCV RNA 24 weeks after end of treatment [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retention in treatment, compliance, psychological distress, measures of quality of life, perceived drug use control and urine toxicology [ Time Frame: 2, 4, 8, 14 and 24 weeks after study start ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2006
Study Completion Date: January 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ribavirin
    800 mg pr. os daily, 400 mg morning and 400 mg evening (200 mg/tbl.) for 14 weeks
    Drug: Pegylated Interferon
    180 mikrogram in 0,5 ml solution s.c. once a week for 14 weeks
Detailed Description:

Chronic infection with the hepatitis C virus (HCV) is a health problem worldwide. In Norway, there are about 3000 patients participating in Methadone Maintenance Treatment(MMT) programs. A prevalence study at the MMT treatment unit in Kristiansand, showed that more than 90 % of 177 patients have been infected with hepatitis C.

A major problem with anti-HCV treatment for this group is the lack of compliance and retention in treatment. Further, due to the high incidence of psychological disorders in opioid dependent patients, this may also complicate anti-HCV treatment. Drug addicted in MMT treatments programs may find themselves excluded from Hepatitis C treatment.

Due to better treatment efficacy with the new PEG-INF's and encouraging reports from 14 weeks studies, it may be easier to motivate opioid dependents to fulfill treatment. Weekly psychological follow-up of these patients will further increase the possibility of opioid dependents in MMT to be able to complete anti-HCV treatment.

The aim of this study is to focus on this patients situation, and strengthen their possibility to have a real opportunity to get treatment. We therefore wish to make a pilot study to investigate the feasibility, efficacy and psycological side-effects of the treatment.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Serologic evidence of hepatitis C infection, genotype 2 and 3
  • Normal or elevated serum ALT activity
  • In MMT-programme and with at least 6 months with satisfactory drug abuse control. That means no iv injections and no or minimal use of drugs.
  • Male and female patients

Exclusion Criteria:

  • Women with ongoing pregnancy or breast feeding
  • Untreated serious psychiatric disorders, particularly depression.
  • Serious drug abuse or alcohol abuse last 6 months
  • Intravenous drug abuse last 6 months
  • Hepatitis A, B or HIV infection
  • HCV genotype 1, 4, 5 and 6
  • Leucocytes < 3000 cells/mm3 at screening (neutrophil count <1500 cells/mm3)
  • Platelet count < 80 000 cells/mm3 at screening
  • Hb <11 g/dL in women or <12 g/dL in men at screening
  • Documented or presumed coronary artery disease or cerebrovascular disease
  • Thyroid dysfunction not adequately controlled
  • Epilepsy
  • Malignant disease
  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: NCT00147784

Locations
Norway
Addiction Unit, Sorlandet Hospital
Kristiansand, Vest-Agder, Norway, N-4604
Soerlandet Hospital HF
Kristiansand, Vest-Agder, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Principal Investigator: Oistein Kristensen, MD Soerlandet Hospital HF
Principal Investigator: Oistein Kristensen, MD Addiction Unit, SSHF
  More Information

No publications provided by Sorlandet Hospital HF

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oistein Kristensen, MD, Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00147784     History of Changes
Other Study ID Numbers: SSHF-70332, Protocol no 9772387, EudraCT no 2005-002869-37
Study First Received: September 6, 2005
Last Updated: March 26, 2008
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Sorlandet Hospital HF:
Chronical Hepatitis C treatment
Methadone Maintenance Treatment
Pegylated Interferon and Ribavirin
14 weeks treatment
Genotype 2 and 3

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
Interferons
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014