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

Sponsored by:	Sorlandet Hospital HF
Information provided by:	Sorlandet Hospital HF
ClinicalTrials.gov Identifier:	NCT00147784

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 III

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Methadone Methadone hydrochloride Ribavirin Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

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:

800 mg pr. os daily, 400 mg morning and 400 mg evening (200 mg/tbl.) for 14 weeks

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147784

Locations

Norway, Vest-Agder
Soerlandet Hospital HF
Kristiansand, Vest-Agder, Norway, 4604
Addiction Unit, Sorlandet Hospital
Kristiansand, Vest-Agder, Norway, N-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

Responsible Party:	Sorlandet Hospital HF ( Oistein Kristensen, MD )
Study ID Numbers:	SSHF-70332, Protocol no 9772387, EudraCT no 2005-002869-37
Study First Received:	September 6, 2005
Last Updated:	March 26, 2008
ClinicalTrials.gov Identifier:	NCT00147784
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Sorlandet Hospital HF:

Chronical Hepatitis C treatment
Methadone Maintenance Treatment
Pegylated Interferon and Ribavirin
14 weeks treatment
Genotype 2 and 3

Study placed in the following topic categories:

Liver Diseases
Ribavirin
Interferons
Hepatitis, Viral, Human
Disorders of Environmental Origin
Opioid-Related Disorders
Hepatitis

Virus Diseases
Methadone
Digestive System Diseases
Mental Disorders
Substance-Related Disorders
Hepatitis C

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections

Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009