Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01288209
Status:
COMPLETED
Last Update Posted:
2014-01-24
First Post:
2011-02-01
Brief Title:
A Phase III Study of TMC435 in Genotype 1 Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy
Sponsor:
Janssen Pharmaceutical KK
Organization:
Janssen Pharmaceutical KK
Study Overview
Official Title:
A Phase III Randomized Open-label Two-arm Trial in Japan to Investigate the Efficacy and Safety of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Hepatitis C Genotype 1-Infected Subjects Who Failed to Respond to Previous IFN-based Therapy
Status:
COMPLETED
Status Verified Date:
2013-12
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 evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a PegIFNα-2a and ribavirin in genotype 1 hepatitis C virus HCV-infected participants who failed to respond to previous interferon IFN-based therapy in Japan
Detailed Description:
This is a randomized study drug assigned by chance 2-arm open-label study to evaluate the efficacy and safety of TMC435 also referred to as jnj-38733214-aaa in combination with the standard of care SoC therapy consisting of peginterferon alfa-2a PegIFNα-2a and ribavirin RBV administered according to the manufacturers prescribing information in adult genotype 1 hepatitis C virus HCV-infected participants who failed to respond to previous interferon IFN-based therapy in Japan The study objective is to evaluate the efficacy of TMC435 by the proportion of participants with undetectable HCV ribonucleic acid RNA Participants will receive 12 weeks of treatment with TMC435 100 mg once daily plus PegIFNα-2a P and RBV P followed by 12 or 36 weeks of treatment with PR OR participants will receive 24 weeks of treatment with TMC435 100 mg once daily plus PR followed by 24 weeks of treatment with PR TMC435 is a 100-mg capsule and will be taken orally via the mouth Treatment with PR will last 24 or 48 weeks Pegylated interferon is supplied as a vial containing 10 mL solution with 180 mcg PegIFNα-2a and will be injected by a syringe under the skin once weekly Ribavirin is given as 200-mg tablets daily dose 600-1000 mg based on body weight and taken orally by mouth two times a day after meals Participants will receive oral capsules of TMC435 100 mg once daily up to Week 12 or 24
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 |
|---|---|---|---|
| TMC435HPC3004 | OTHER | Janssen Pharmaceutical KK Japan | None |