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

NCT ID: NCT00147784

Last Updated: 2008-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-01-31

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

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.

Conditions

Opiate Dependence; Hepatitis

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Ribavirin

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

Intervention Type: DRUG

Pegylated Interferon

180 mikrogram in 0,5 ml solution s.c. once a week for 14 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sorlandet Hospital HF

Principal Investigators

Oistein Kristensen, MD

Role: PRINCIPAL_INVESTIGATOR

Soerlandet Hospital HF

Oistein Kristensen, MD

Role: PRINCIPAL_INVESTIGATOR

Addiction Unit, SSHF

Locations

Soerlandet Hospital HF

Kristiansand, Vest-Agder, Norway

Addiction Unit, Sorlandet Hospital

Kristiansand, Vest-Agder, Norway

Countries

Norway

References

Kristensen O, Sundoy A, Skeie K, Vederhus JK, Oye I, Opsal A, Rysstad O, Gallefoss F. [Short-term treatment of Hepatitis C in heroin-dependent patients]. Tidsskr Nor Laegeforen. 2009 Aug 27;129(16):1639-42. doi: 10.4045/tidsskr.09.33690. Norwegian.

Reference Type: DERIVED

PMID: 19721480 (View on PubMed)

Other Identifiers

Protocol no 9772387

Identifier Type: -

Identifier Source: secondary_id

EudraCT no 2005-002869-37

Identifier Type: -

Identifier Source: secondary_id

SSHF-70332

Identifier Type: -

Identifier Source: org_study_id