Hepatitis C Treatment of Inmates (PEGPRI)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- - adherence
- - Sustained virologic response rates defined as percentage of patients with non-detectable HCV-RNA as measured by Roche AMPLICOR HCV Test, v2.0 (>50 IU/mL).
- Percentage of patients with non-detectable HCV-RNA at study week 12, 24 and 48 as measured by Roche AMPLICOR HCV Test v2.0 (<50 IU/mL).
- - adverse event rate and profile
- - Hemoglobin
- - Other laboratory tests
- - Medical Outcomes Study 36 Item Short Form health Survey (SF-36)
|Study Start Date:||August 2003|
|Estimated Study Completion Date:||July 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
|Unit for infectious diseases outpatient clincic, Dept. Internal Medicine|
|Bergen, Norway, N-5021|
|Principal Investigator:||Steinar Skrede, M.D., Ph.D.||Unit for infectious diseases, Dept. Internal Medicine, Haukeland UH|