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NCT01349465 · ClinicalTrials.gov registry record · Phase 3
3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection
A Phase 3 study, sponsored by Janssen R&D Ireland.
- Completed
- Registry status
- Phase 3
- Development phase
- 249
- Enrollment target
NCT01349465: Completed Phase 3 study, sponsored by Janssen R&D Ireland.
NCT01349465 is a Phase 3 study that has completed, run by Janssen R&D Ireland. The registered enrollment target is 249 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01349465, a Phase 3 study, has completed, sponsored by Janssen R&D Ireland.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 249 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.
Primary Outcome
The SVR rate is the proportion (%) of participants with HCV RNA less than (\<) 25 International Units/milliliter (IU/mL).
Interventions
- DRUG No treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2011-07-04 |
| Est. Completion | 2016-01-05 |
| Phase | Phase 3 |
What the finished NCT01349465 record still lists
NCT01349465 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which No treatment is the first listed.
NCT01349465 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01349465 about?
NCT01349465 is a clinical study titled "3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection". The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TM...
What is the current status of trial NCT01349465?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 249 participants. The study started on 2011-07-04. Estimated completion is 2016-01-05.
What interventions are being tested in trial NCT01349465?
The interventions under investigation include: No treatment (DRUG).
Who is sponsoring clinical trial NCT01349465?
This trial is sponsored by Janssen R&D Ireland, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01349465's enrollment target sits among peer trials
249 1266th of 2000 higher than 735 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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