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Study of Treatment and Metabolism in Patients With Urea Cycle Disorders

NCT00004307 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2005-06-24

No results posted yet for this study

Summary

RATIONALE: The urea cycle is the process in which nitrogen is removed from the blood and converted into urea, a waste product found in urine . Urea cycle disorders are inherited disorders caused by the lack of an enzyme that removes ammonia from the bloodstream. Gene therapy is treatment given to change a gene so that it functions normally. Studying the treatment and metabolism of patients with urea cycle disorders may be helpful in developing new treatments for these disorders.

PURPOSE: Two-part clinical trial to study the treatment and metabolism of patients who have urea cycle disorders.

Conditions

  • Amino Acid Metabolism, Inborn Errors

Interventions

BEHAVIORAL

Protein and calorie controlled diet

GENETIC

Ornithine transcarbamylase vector

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Brendan Lee · Baylor College of Medicine

Study Design

Purpose
TREATMENT

Eligibility

Min Age
6 Months
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004307 on ClinicalTrials.gov