Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01498068
Status:
COMPLETED
Last Update Posted:
2015-01-30
First Post:
2011-12-06
Brief Title:
Open-Label Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
Sponsor:
Janssen-Cilag International NV
Organization:
Janssen-Cilag International NV
Study Overview
Official Title:
Open-Label Bridging Study to Determine Efficacy and Safety of Telaprevir Pegylated-Interferon-alfa-2a and Ribavirin in Treatment- Naïve and Treatment-Experienced Russian Subjects With Genotype 1 Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2015-01
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:
The purpose of this study is to determine the effectiveness safety and tolerability of telaprevir administered as 750 mg every 8 hours q8h in combination with pegylated interferon Peg-IFN-alfa-2a and ribavirin RBV in treatment-naïve and treatment-experienced Russian participants with genotype 1 chronic hepatitis C
Detailed Description:
This is an open-label all persons know the study drug assignment multicenter study in treatment-naïve participant did not receive any previous treatment for the treatment of hepatitis C and treatment-experienced participant did receive previous treatment for hepatitis C Russian participants with genotype 1 chronic hepatitis C After a screening period of approximately 4 weeks participants will be treated for 12 weeks with telaprevir 750 mg every 8 hours in combination with Peg-IFN-alfa-2a and RBV followed by 12 or 36 weeks of treatment with Peg-IFN-alfa-2a and RBV alone depending on their liver disease status response to previous treatment and individual virologic response during treatment in this study After the treatment period there is a follow-up phase of at least 12 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VX-950HPC3007 | OTHER | Janssen-Cilag International NV Belgium | None |