MedTrace Logo

Response to Phenylketonuria to Tetrahydrobiopterin (BH4)

NCT00244218 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-09-21

No results posted yet for this study

Summary

The purpose of this study is to determine whether tetrahydrobiopterin (BH4)is effective in treating patients with PKU.

Conditions

Interventions

DRUG

tetrahydrobiopterin (BH4)

Either placebo or tetrahydrobiopterin (BH4) , 10mg/kg/day will be given for three months. Then the patient will be given three additional months of open label BH4 at the same rate.

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Reuben Matalon, MD, PhD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2009-03-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00244218 on ClinicalTrials.gov