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NCT00260208 · ClinicalTrials.gov registry record · Phase 4
Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 361
- Enrollment target
NCT00260208: Clinical Trial Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT00260208 is a Phase 4 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 361 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00260208, a Phase 4 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 361 participants
- Enrollment target
Study Summary
Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver. The aim of this study was to see if the frequency of liver fibrosis was different with cyclosporine microemulsion than tacrolimus
Primary Outcome
Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. Logistic regression on the presence of IK\>=2 was applied
Interventions
- DRUG Tacrolimus
- DRUG Cyclosporine A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 361 participants |
| Start Date | 2006-01 |
| Phase | Phase 4 |
Why NCT00260208 stopped before completion
NCT00260208 is an interventional study that assigns participants to a tested intervention. The registered 361 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Tacrolimus is the first listed.
NCT00260208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00260208 about?
NCT00260208 is a clinical study titled "Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus". Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver. The aim of this study was to see if the frequency of liver fibrosis was different with cyclosporine microemulsion than tacrolimus
What is the current status of trial NCT00260208?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 361 participants. The study started on 2006-01.
What interventions are being tested in trial NCT00260208?
The interventions under investigation include: Tacrolimus (DRUG), Cyclosporine A (DRUG).
Who is sponsoring clinical trial NCT00260208?
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 NCT00260208's enrollment target sits among peer trials
361 225th of 2000 higher than 1,776 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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