TMC435HPC3002 - 3-Year Follow up of Patients After Administration of TMC435 for the Treatment of Chronic Hepatitis C.

Registry ID
EUCTR2010-019843-20
Source registry
EUCTR
Status
Completed
Phase
PHASE3
Sponsor
Janssen R&D Ireland
Start date
2010-09-27
Completion date
2016-01-05
Last update
2026-08-16

Conditions

Summary

- To evaluate the durability of sustained virologic response (SVR) in subjects who were treated with a TMC435- containing regimen in a previous Phase IIb or Phase III study and maintained undetectable HCV ribonucleic acid (RNA) until the last planned visit of that previous study (LPVPS). - To evaluate sequence changes in the HCV NS3/4A region over time in subjects who were treated with a TMC435-containing regimen in a previous Phase IIb or Phase III study and had confirmed detectable HCV RNA at the LPVPS.

Locations

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