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ACTIVE NOT RECRUITING
NCT07255599
PHASE1

Evaluation of BH4 Responsiveness in Our PKU Patients

Sponsor: Sohag University

View on ClinicalTrials.gov

Summary

This study aims to evaluate BH4 responsiveness in our PKU patients and to correlate BH4 responsiveness with their genotype

Official title: Tetrahydrobiopterin Responsiveness in Phenylketonuria Prediction With the 48-hour Loading Test and Genotype

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-09-01

Completion Date

2026-09-01

Last Updated

2025-12-01

Healthy Volunteers

No

Interventions

DRUG

Sapropterin Dihydrochloride (BH4, tetrahydrobiopterin)

Patients were supplemented with phenylalanine a protein rich supplement based on milk protein, or an increase in natural protein intake) if phenylalanine was \< 400 μmol/l. BH4 20 mg/kg was administered at T = 0 and T = 24. Blood samples were taken at T = 0, 8, 16, 24 and 48 h. Responsiveness was defined as ≥ 30% reduction in phenylalanine concentration at ≥ 1 time point.

Locations (1)

Sohag Faculty of Medicine

Sohag, Egypt