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NCT00938860 · ClinicalTrials.gov registry record · Phase 4
Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 92
- Enrollment target
NCT00938860: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT00938860 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 92 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00938860, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 92 participants
- Enrollment target
Study Summary
This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatitis C and treated with Neoral or tacrolimus.
Primary Outcome
The achievement of SVR, defined as HCV RNA below limit of detection at the end of AV treatment, 24 weeks after end of AV treatment (W24 post). A dichotomous variable (SVR achieved: Yes/No) was computed. A patient was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at W24post, or at any time between W24 and completion of antiviral treatment. The HCV RNA detection limit was \<15 IU/ml (\<1.18 log IU/ml)
Interventions
- DRUG cyclosporin (Neoral)
- DRUG tacrolimus (Prograf)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
What the finished NCT00938860 record still lists
NCT00938860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which cyclosporin (Neoral) is the first listed.
NCT00938860 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00938860 about?
NCT00938860 is a clinical study titled "Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C". This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatitis C and treated with Neoral or tacrolimus.
What is the current status of trial NCT00938860?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 92 participants. The study started on 2009-09. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00938860?
The interventions under investigation include: cyclosporin (Neoral) (DRUG), tacrolimus (Prograf) (DRUG).
Who is sponsoring clinical trial NCT00938860?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00938860's enrollment target sits among peer trials
92 876th of 2000 higher than 1,117 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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