Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261) (SUPPORT)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: August 1, 2008
Last Update Posted: October 9, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the approved European labeling. The study will assess the tolerability, safety and efficacy of the treatment with PegIntron plus Rebetol in this study population. The objective of the study is to collect data on the prevalence of the hepatitis C infections in drug-substituted patients. The study will also compare the feasibility of HCV (Hepatitis C Virus) treatment in patients receiving Subutex® vs other drug substitution pharmacotherapies.
|Hepatitis C, Chronic Substance Abuse, Intravenous||Biological: PegIntron (pegylated interferon alfa-2b; SCH 54031) Drug: Rebetol (ribavirin; SCH 18908)|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Quality Assurance of HCV-therapy With PegIntron® Plus Rebetol® in Drug-substituted Patients - SUPPORT Project Post-Marketing Surveillance Study|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions [ Time Frame: End of Follow-up (Week 48 or Week 72, depending on genotype) ]Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).
- Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week [ Time Frame: Assessed at the end of treatment ]Tolerability of the treatment was measured by number of participants with complete treatment.
|Study Start Date:||October 2005|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
PegIntron + Rebetol
There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters).
Biological: PegIntron (pegylated interferon alfa-2b; SCH 54031)
PegIntron 1.5 μg/kg/week administered for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue PegIntron therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4
Other Name: SCH 54031Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered at 10.6 mg/kg/day for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue Rebetol therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4
Other Name: SCH 18908
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