Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT01066793
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2010-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons.
Status:
COMPLETED
Status Verified Date:
2016-04
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 observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is \<2000.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: