# Long-Term Tetrahydrobiopterin Treatment in PKU Patients of 0-18 Years - Study on Phenylalanine Tolerance and Safety

> **NCT00432822** · PHASE2,PHASE3 · TERMINATED · sponsor: **Orphanetics Pharma Entwicklungs GmbH** · enrollment: 50 (estimated)

## Conditions studied

- Phenylalanine Hydroxylase Deficiencies

## Interventions

- **DRUG:** tetrahydrobiopterin (BH4)

## Key facts

- **NCT ID:** NCT00432822
- **Lead sponsor:** Orphanetics Pharma Entwicklungs GmbH
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** —
- **Primary completion:** —
- **Final completion:** —
- **Target enrollment:** 50 (ESTIMATED)
- **Last updated:** 2007-09-20


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00432822

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00432822, "Long-Term Tetrahydrobiopterin Treatment in PKU Patients of 0-18 Years - Study on Phenylalanine Tolerance and Safety". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT00432822. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
