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A Long-Term Safety Study of PTC923 in Participants With Phenylketonuria

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Contents

clinicaltrials.gov/study/NCT05166161
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT051661610
Health Conditions in Trial
Phenylketonuria
Phenylketonuria
0
Trial Recruitment Size
2000
Trial Sponsor
PTC Therapeutics
PTC Therapeutics
0
Clinical Trial Start Date
February 14, 2022
0
Primary Completion Date
February 7, 2025
0
Study Completion Date
February 7, 2025
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
PTC9230
Interventional Trial Phase
Phase 30
Participating Facility
Westmead Hospital
Westmead Hospital
0
‌
Indiana University School of Medicine
0
‌
Universitätsklinikum Münster
0
Royal Children's Hospital
Royal Children's Hospital
0
Great Ormond Street Hospital
Great Ormond Street Hospital
0
Official Name
A Phase 3 Open-Label Study of PTC923 (Sepiapterin) in Phenylketonuria0
Last Updated
December 8, 2023
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study summary

The main purpose of this study is to evaluate the long-term safety of PTC923 in participants with phenylketonuria, and to evaluate the changes from baseline in dietary phenylalanine (Phe)/protein consumption.

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