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NCT01207141 · ClinicalTrials.gov registry record
rATG Induction and Tacrolimus Monotherapy in Pediatric Liver Transplantation
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 110
- Enrollment target
NCT01207141 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 110 participants.
The verdict
NCT01207141 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 110 participants
- Enrollment target
Study Summary
This open-label clinical trial will evaluate the pharmacodynamics, pharmacogenomics and early efficacy and safety of steroid-free Tacrolimus (TAC) monotherapy and its minimization after induction with rabbit, anti-human thymocyte globulin (rATG, Genzyme, Cambridge, MA) in children and adults with pediatric liver transplantation. Eighty subjects (0-21 years) receiving liver transplantation will be enrolled. Incidence and severity of biopsy-proven acute cellular rejection (ACR) is a primary endpoint as well as time to Tacrolimus whole blood concentrations \<8 ng/ml The expected incidence of ACR is 50% and is derived from a non-consecutive subject population (n=40) who received an identical regimen in IND 64555. This incidence is acceptable because the long term sequel of rejection reported with other allografts have not been observed in liver grafts during IND 64555. These risks are further negated by the unique regenerative capacity of the liver allograft. An OBSERVATIONAL arm is being included in this trial. Because the numbers of pediatric liver transplants (LTx) are small in any single center setting, no information is known about relative outcomes on a conventional protocol, in children receiving conventional protocol of steroids+Tacrolimus. The PURPOSE of this additional recruitment is OBSERVATIONAL, only. Therefore, these subjects will NOT be randomized. Rather, by studying all types of patients, the investigators hope to utilize maximally, all available subjects, to understand the relative place of monotherapeutic induction. In turn, this will be the basis for a follow-up comparative, randomized trial.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2006-08 |
| Est. Completion | 2019-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01207141
The ClinicalTrials.gov registry entry for NCT01207141 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01207141 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01207141 about?
NCT01207141 is a clinical study titled "rATG Induction and Tacrolimus Monotherapy in Pediatric Liver Transplantation". This open-label clinical trial will evaluate the pharmacodynamics, pharmacogenomics and early efficacy and safety of steroid-free Tacrolimus (TAC) monotherapy and its minimization after induction with rabbit, anti-human thymocyte globulin (rATG, Genzyme, Cambridge, MA) in children and adults with pe...
What is the current status of trial NCT01207141?
This trial is currently completed. The enrollment target is 110 participants. The study started on 2006-08. Estimated completion is 2019-05.
Who is sponsoring clinical trial NCT01207141?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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