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NCT05166161 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Phenylketonuria, sponsored by PTC Therapeutics.

Active
Registry status
Phase 3
Development phase
200
Enrollment target
20
Study locations

NCT05166161 is a Phase 3 study of Phenylketonuria that is active but no longer recruiting, run by PTC Therapeutics. The registered enrollment target is 200 participants, above the 82-participant average among 12 other Phenylketonuria trials with a reported enrollment target (144% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT05166161, a Phase 3 study of Phenylketonuria, is active but no longer recruiting, sponsored by PTC Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
200 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Phenylketonuria

Interventions

  • DRUG PTC923

Study Locations (20)

Other

  • Fakultní nemocnice Královské Vinohrady Klinika dětí a dorostu Ambulance pro léčbu PKU a HPA - Prague
  • Copenhagen University Hospital, Rigshospitalet - Copenhagen
  • Hôpital Necker-Enfants Malades - Centre de Référence des Maladies Héréditaires du Métabolisme - Paris
  • Medical Genetics and Laboratory Diagnostics Center - Tbilisi
  • University Children's Hospital Hamburg Eppendorf (Kinder-UKE) Klinik für Kinder- und Jugendmedizin (Kinder-UKE) - Hamburg

Ontario

  • McMaster Children's Hospital Hamilton Health Sciences - Hamilton
  • The Hospital for Sick Children University of Toronto Adult Clinic: The Fred A Litwin Family Centre in Genetic Medicine University Health Network & Mt. Sinai Hospital - Toronto

Colorado

  • Children's Hospital Colorado - Aurora

Florida

  • UF College of Medicine, Department of Pediatrics Division of Genetics and Metabolism - Gainesville

Indiana

  • Indiana University School of Medicine Department of Medical and Molecular Genetics - Indianapolis

Massachusetts

  • Boston Children's Hospital - Boston

New York

  • Icahn School of Medicine at Mount Sinai (ISMMS) - New York

Pennsylvania

  • UPMC Children's Hospital of Pittsburgh - Pittsburgh

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2022-02-14
Est. Completion 2026-06-30
Phase Phase 3

Sponsor

PTC Therapeutics

52 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05166161

The ClinicalTrials.gov registry entry for NCT05166161 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 82-participant average among 12 other Phenylketonuria trials with a reported enrollment target (144% higher). The listed sponsor is PTC Therapeutics, which has 52 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Phenylketonuria appearing as the primary indexed condition, and to 1 intervention - of which PTC923 is the first listed.

NCT05166161 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, Ontario, Colorado.

Frequently Asked Questions

What is clinical trial NCT05166161 about?

NCT05166161 is a clinical study titled "A Long-Term Safety Study of PTC923 in Participants With Phenylketonuria". 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.

What is the current status of trial NCT05166161?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2022-02-14. Estimated completion is 2026-06-30.

What conditions does trial NCT05166161 study?

This clinical trial studies the following conditions: Phenylketonuria.

What interventions are being tested in trial NCT05166161?

The interventions under investigation include: PTC923 (DRUG).

Who is sponsoring clinical trial NCT05166161?

This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05166161 being conducted?

This trial has 20 study locations across Colorado, Florida, Indiana, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.