Status:
COMPLETED
HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group.
Lead Sponsor:
Sorlandet Hospital HF
Conditions:
Opiate Dependence
Hepatitis
Eligibility:
All Genders
25-50 years
Phase:
PHASE3
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 n...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00147784
Start Date
March 1 2006
End Date
January 1 2008
Last Update
March 28 2008
Active Locations (2)
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1
Soerlandet Hospital HF
Kristiansand, Vest-Agder, Norway, 4604
2
Addiction Unit, Sorlandet Hospital
Kristiansand, Vest-Agder, Norway, N-4604