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NCT02165189 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant
A Phase 2 study, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT02165189: Completed Phase 2 study, sponsored by Janssen Scientific Affairs.
NCT02165189 is a Phase 2 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02165189, a Phase 2 study, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate sustained virologic response 12 weeks after the end of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without ribavirin (RBV) and 24 weeks of simeprevir plus sofosbuvir without RBV in post orthotopic liver transplant participants with recurrent hepatitis (inflammation of the liver) C virus (HCV) Genotype 1 infection.
Primary Outcome
Participants will be considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (\<) 15 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the end of treatment. End of treatment is at Week 12 (for Arms 1 and 2) or Week 24 (for Arm 3); therefore, outcome will be measured at Week 24 (for Arms 1 and 2) or Week 36 (for Arm 3).
Interventions
- DRUG Ribavirin
- DRUG Sofosbuvir
- DRUG Simeprevir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
What the finished NCT02165189 record still lists
NCT02165189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT02165189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02165189 about?
NCT02165189 is a clinical study titled "An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant". The purpose of this study is to evaluate sustained virologic response 12 weeks after the end of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without ribavirin (RBV) and 24 weeks of simeprevir plus sofosbuvir without RBV in post orthotopic liver transplant participants ...
What is the current status of trial NCT02165189?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2014-08. Estimated completion is 2015-11.
What interventions are being tested in trial NCT02165189?
The interventions under investigation include: Ribavirin (DRUG), Sofosbuvir (DRUG), Simeprevir (DRUG).
Who is sponsoring clinical trial NCT02165189?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02165189's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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