A Phase 3 interventional study of Ribavirin and Pegylated Interferon in Opiate Dependence and Hepatitis, sponsored by Sorlandet Hospital HF. Completed at 2 sites in Norway. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2008-03-28.
Sponsored by Sorlandet Hospital HF · Phase 3, Interventional, and Treatment
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 10 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Sorlandet Hospital HF is the lead sponsor of 73 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
- 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
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
This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.
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Sorlandet Hospital HF