Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)
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.
The objective of the study is to assess the safety and efficacy of PegIntron injector and Rebetol administered to participants with chronic hepatitis C. Participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study will assess the rates of eradication of the hepatits C virus and the rates of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200 mg/day) in common medical practice in Germany.
|Hepatitis C, Chronic Hepatitis C||Biological: PegIntron (peginterferon alfa-2b; SCH 54031) injector Drug: Rebetol (ribavirin; SCH 18908)|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Treatment of Chronic Hepatitis C With PegIntron Injector and Rebetol (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 Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT) [ Time Frame: 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6 ]HCV-RNA level was measured by polymerase chain reaction (PCR).
- Number of Participants With Early Virologic Response (EVR) [ Time Frame: Treatment Week 12 ]
EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA
negativity from baseline to Week 12
- Number of Participants With Sustained Virologic Response (SVR) [ Time Frame: 24 weeks post-treatment (Week 48 or 72, depending on genotype) ]SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT
- Number of HCV-RNA Negative Participants at Follow-up [ Time Frame: 24 weeks post-treatment (Weeks 48 or 72, depending on genotype) ]HCV-RNA was measured by PCR.
|Study Start Date:||August 2005|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
PegIntron + Rebetol
Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy
Biological: PegIntron (peginterferon alfa-2b; SCH 54031) injector
PegIntron administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling
Other Name: SCH 54031Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling
Other Name: SCH 18908
Contacts and Locations
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