Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT01498068
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:
NCT01498068
Study Brief:
Protocol Section:
NCT01498068