Ignite Creation Date:
2024-05-05 @ 11:05 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01258101
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2010-11-29
Brief Title:
A Study of PEGASYS Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C CHC Genotype 2 or 3
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
Randomized Multicenter Study to Compare the Efficacy of Pegylated Interferon Alfa PEG-IFN in Combination With Two Different Doses of Ribavirin in Patients With Chronic Hepatitis C and Subtype 23
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized parallel arm study will evaluate the efficacy and safety of Pegasys peginterferon alfa-2a in combination with 2 different doses of ribavirin in patients with chronic hepatitis C genotype 2 or 3 Patients will be randomized to 4 treatment groups receiving Pegasys 180 mcg subcutaneously weekly for either 16 or 24 weeks with one of two doses of ribavirin 400 mg or 800 mg orally daily The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up
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