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N-Carbamylglutamate (Carbaglu) In The Treatment Of Hyperammonemia

NCT00843921 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-02-17

No results posted yet for this study

Summary

This study is based on the hypothesis that a new drug N-carbamylglutamate (Carbaglu®) will enhance the ability of the liver to dispose of toxic ammonia which accumulates in several metabolic diseases including urea cycle disorders and organic acid disorders.

Conditions

  • Inborn Errors of Metabolism

Interventions

DRUG

N-carbamylglutamate

100 mg/kg/day or 2.2 g/M2/day in 3-4 divided doses for 3 days

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Mendel Tuchman

    lead OTHER

Principal Investigators

  • Mendel Tuchman, MD · Children's National Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2018-04-25
Completion
2020-06-30

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 NCT00843921 on ClinicalTrials.gov