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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00147784
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : March 28, 2008
Information provided by:
Sorlandet Hospital HF

Brief Summary:
  • 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 or disease Intervention/treatment Phase
Opiate Dependence Hepatitis Drug: Ribavirin Drug: Pegylated Interferon Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

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

Primary Outcome Measures :
  1. - 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00147784

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Oistein Kristensen, MD, Sorlandet Hospital HF Identifier: NCT00147784     History of Changes
Other Study ID Numbers: SSHF-70332
Protocol no 9772387
EudraCT no 2005-002869-37
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008

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 A
Hepatitis C
Opioid-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents