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Sponsors and Collaborators: |
Haukeland University Hospital Bergen fengsel, N-5971 BERGEN Hoffmann-La Roche |
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Information provided by: | Haukeland University Hospital |
ClinicalTrials.gov Identifier: | NCT00209898 |
Hepatitis C infection is a prevalent chronic disease. It is particularly prevalent among intravenous drug abusers. Bergen fengsel is a regional prison housing 250 inmates, of which as many as 70 are recorded HCV RNA PCR positive annuallly. In this study inmate males and females will be randomized to standard screening and initiation procedure, or to a rapid initiation procedure in the hospital's infectious diseases outpatient clinic. The study aims at studying if rapid inclusion will increase the possibility to conclude treatment while the prisoner still is incarcerated, thus improve the chances of reaching a sustained virologic response, compared to standard inclusion, where prisoners, as other out patients will wait for inclusion for several months.
Condition | Intervention |
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Chronic Hepatitis C |
Procedure: Fast initiation procedure |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Hepatitis C Treatment of Inmates. A Randomized, Open-Label Study Evaluating the Feasibility, Safety and Efficacy of Treatment With Peginterferon Alfa-2a in Combination With Ribavirin in Inmate Patients With Chronic Hepatitis C |
Estimated Enrollment: | 100 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | September 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Steinar Skrede, M.D., Ph.D. | +4755972977 | sskr@helse-bergen.no |
Contact: Nina Langeland, M.D., Ph.D, Prof. | +4755972961 | nila@helse-bergen.no |
Norway | |
Unit for infectious diseases outpatient clincic, Dept. Internal Medicine | Recruiting |
Bergen, Norway, N-5021 | |
Contact: Steinar Skrede, M.D., Ph.D +4755973013 sskr@helse-bergen.no | |
Contact: Nina Langeland, Prof., M.D., Ph.D. +4755972961 nila@helse.bergen.no |
Principal Investigator: | Steinar Skrede, M.D., Ph.D. | Unit for infectious diseases, Dept. Internal Medicine, Haukeland UH |
Study ID Numbers: | 12952 |
Study First Received: | September 13, 2005 |
Last Updated: | December 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00209898 |
Health Authority: | Norway: Norwegian Medicines Agency |
- Chronic hepatits C - Peginterferon alfa 2a - Ribavirin - Inmate - Fast initiation procedure |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Ribavirin Peginterferon alfa-2a Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
Anti-Infective Agents RNA Virus Infections Flaviviridae Infections |
Therapeutic Uses Antiviral Agents Pharmacologic Actions |