HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group.
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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. |
- - 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 ]
- 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) |
-
Drug: Ribavirin
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 |
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| Norway | |
| Soerlandet Hospital HF | |
| Kristiansand, Vest-Agder, Norway, 4604 | |
| Addiction Unit, Sorlandet Hospital | |
| Kristiansand, Vest-Agder, Norway, N-4604 | |
| 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 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 Mental Disorders Interferons Ribavirin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013