Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255008
Status:
TERMINATED
Last Update Posted:
2017-04-06
First Post:
2005-11-15
Brief Title:
Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients A Comparison of Race and Genotype on Treatment Outcome Study P04212
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
SEASON South East Asian Study Of Novel Genotypes in Hepatitis C Infection Pegylated-Interferon and Ribavirin Therapy PEGATRON REDIPEN Combination Therapy PEG-Intron REDIPEN Plus REBETOL in Treatment Naive Patients With Genotypes 1 6 7 8 9 A Comparison of Race and Genotype on Treatment Outcome
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated PEG-Interferonribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferonribavirin in Caucasian patients with genotype 1 chronic hepatitis C This study is also designed to provide a randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferonribavirin in Southeastern Asian patients with genotypes 6-9 The primary endpoint is sustained virologic response as defined by negative hepatitis C virus HCV ribonucleic acid RNA in serum at 24 weeks after therapy completion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None