Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00223730 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy Toxicity Reduction Via Urea Cycle Support
A Phase 2 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT00223730 is a Phase 2 study that has completed, run by Vanderbilt University. The registered enrollment target is 100 participants.
The verdict
NCT00223730, a Phase 2 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
Patients undergoing bone marrow transplantation (BMT) and peripheral blood stem cell transplants (PBSCT) frequently develop organ dysfunctions, much of which may be initiated by damage to the liver and to cells lining blood vessels. We, the researchers at Vanderbilt University, propose to perform a randomized, prospective, double-blind, placebo-controlled study of 144 patients undergoing allogeneic marrow transplantation. The treatment is aimed at supporting hepatic urea cycle function in patients receiving escalated dose chemotherapy/BMT. By so doing we hope to prevent development of hepatic venoocclusive disease (HVOD) and acute lung injury (ALI), two morbid complications of BMT. Patients will be randomized to receive oral citrulline, a urea cycle amino acid intermediate, or placebo beginning before conditioning therapy and continuing until 21 days after BMT. All patients will be followed for 100 days after study enrollment with intensive data collection.
Interventions
- DRUG Placebo
- DRUG Citrulline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2001-10 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00223730
The ClinicalTrials.gov registry entry for NCT00223730 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00223730 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00223730 about?
NCT00223730 is a clinical study titled "Chemotherapy Toxicity Reduction Via Urea Cycle Support". Patients undergoing bone marrow transplantation (BMT) and peripheral blood stem cell transplants (PBSCT) frequently develop organ dysfunctions, much of which may be initiated by damage to the liver and to cells lining blood vessels. We, the researchers at Vanderbilt University, propose to perform a...
What is the current status of trial NCT00223730?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2001-10. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00223730?
The interventions under investigation include: Placebo (DRUG), Citrulline (DRUG).
Who is sponsoring clinical trial NCT00223730?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.