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NCT00163657 · ClinicalTrials.gov registry record · Phase 4
Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection
A Phase 4 study of Hepatitis C and End Stage Liver DIsease, sponsored by Baylor Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 312
- Enrollment target
- 1
- Study location
NCT00163657: Completed Phase 4 study of Hepatitis C and End Stage Liver DIsease, sponsored by Baylor Research Institute.
NCT00163657 is a Phase 4 study of Hepatitis C and End Stage Liver DIsease that has completed, run by Baylor Research Institute. The registered enrollment target is 312 participants, below the 1,887-participant average among 106 other Hepatitis C trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00163657, a Phase 4 study of Hepatitis C and End Stage Liver DIsease, has completed, sponsored by Baylor Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 312 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.
Primary Outcome
Freedom from acute rejection (Banff\>grade 2 with RAI score\>4) or freedom from HCV recurrence (Batts/Ludwig\>Stage 2, or \>Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the "Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment
Conditions Studied
Interventions
- DRUG Tacrolimus
- DRUG Cyclosporine
- DRUG MMF
- DRUG Daclizumub
Study Locations (1)
Texas
- Baylor Regional Transplant Institute - Baylor University Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2002-07 |
| Est. Completion | 2007-01 |
| Phase | Phase 4 |
What the finished NCT00163657 record still lists
NCT00163657 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, below the 1,887-participant average among 106 other Hepatitis C trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Hepatitis C appearing as the primary indexed condition, and to 4 interventions - of which Tacrolimus is the first listed.
NCT00163657 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00163657 about?
NCT00163657 is a clinical study titled "Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection". The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.
What is the current status of trial NCT00163657?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 312 participants. The study started on 2002-07. Estimated completion is 2007-01.
What conditions does trial NCT00163657 study?
This clinical trial studies the following conditions: Hepatitis C, End Stage Liver DIsease.
What interventions are being tested in trial NCT00163657?
The interventions under investigation include: Tacrolimus (DRUG), Cyclosporine (DRUG), MMF (DRUG), Daclizumub (DRUG).
Who is sponsoring clinical trial NCT00163657?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00163657 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis C
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00163657's enrollment target sits among peer trials
312 35th of 106 higher than 72 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C 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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