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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 is a Phase 2 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 46 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02165189
The ClinicalTrials.gov registry entry for NCT02165189 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Scientific Affairs, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT02165189 reports 0 study locations.
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.
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