HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group.
3 other identifiers
interventional
10
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedMarch 28, 2008
March 1, 2008
1.3 years
September 6, 2005
March 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
- Percent of patients with sustained virological response, defined as undetectable HCV RNA 24 weeks after end of treatment
24 weeks after end of treatment
Secondary Outcomes (1)
Retention in treatment, compliance, psychological distress, measures of quality of life, perceived drug use control and urine toxicology
2, 4, 8, 14 and 24 weeks after study start
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Soerlandet Hospital HF
Kristiansand, Vest-Agder, 4604, Norway
Addiction Unit, Sorlandet Hospital
Kristiansand, Vest-Agder, N-4604, Norway
Related Publications (1)
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.
PMID: 19721480DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oistein Kristensen, MD
Soerlandet Hospital HF
- PRINCIPAL INVESTIGATOR
Oistein Kristensen, MD
Addiction Unit, SSHF
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 7, 2005
Study Start
March 1, 2006
Primary Completion
June 1, 2007
Study Completion
January 1, 2008
Last Updated
March 28, 2008
Record last verified: 2008-03