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NCT00345605 · ClinicalTrials.gov registry record · Phase 2
Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle Disorder
A Phase 2 study of Urea Cycle Disorders and Argininosuccinic Aciduria, sponsored by Brendan Lee.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT00345605: Completed Phase 2 study of Urea Cycle Disorders and Argininosuccinic Aciduria, sponsored by Brendan Lee.
NCT00345605 is a Phase 2 study of Urea Cycle Disorders and Argininosuccinic Aciduria that has completed, run by Brendan Lee. The registered enrollment target is 12 participants, below the 394-participant average among 4 other Urea Cycle Disorders trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00345605, a Phase 2 study of Urea Cycle Disorders and Argininosuccinic Aciduria, has completed, sponsored by Brendan Lee.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Urea cycle disorders are inherited illnesses in which the body does not produce enough of the chemicals that remove ammonia, a byproduct of protein metabolism, from the blood stream. Elevated ammonia levels can lead to brain damage and death. Argininosuccinic aciduria (ASA) is a type of urea cycle disorder that is characterized specifically by high levels of argininosuccinic acid, a chemical involved in the urea cycle. People with ASA are at risk for serious liver damage, which may be due to the elevated levels of argininosuccinic acid. Sodium phenylbutyrate (Buphenyl-TM) is a drug that has been used to treat other types of urea cycle disorders. This study will evaluate whether Buphenyl-TM in conjunction with decreased arginine dose (in addition to a normal regimen of protein) will improve short-term liver function and decrease plasma citrulline and ASA levels in people with ASA.
Primary Outcome
Plasma aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were measured.
Conditions Studied
Interventions
- DRUG Arginine
- DRUG Sodium Phenylbutyrate
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
What the finished NCT00345605 record still lists
NCT00345605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 394-participant average among 4 other Urea Cycle Disorders trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Urea Cycle Disorders appearing as the primary indexed condition, and to 2 interventions - of which Arginine is the first listed.
NCT00345605 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00345605 about?
NCT00345605 is a clinical study titled "Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle Disorder". Urea cycle disorders are inherited illnesses in which the body does not produce enough of the chemicals that remove ammonia, a byproduct of protein metabolism, from the blood stream. Elevated ammonia levels can lead to brain damage and death. Argininosuccinic aciduria (ASA) is a type of urea cycle d...
What is the current status of trial NCT00345605?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2008-02. Estimated completion is 2012-11.
What conditions does trial NCT00345605 study?
This clinical trial studies the following conditions: Urea Cycle Disorders, Argininosuccinic Aciduria, Amino Acid Metabolism, Inborn Errors.
What interventions are being tested in trial NCT00345605?
The interventions under investigation include: Arginine (DRUG), Sodium Phenylbutyrate (DRUG).
Who is sponsoring clinical trial NCT00345605?
This trial is sponsored by Brendan Lee, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00345605 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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