Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

June 17, 2022

Primary Completion Date

January 14, 2025

Study Completion Date

October 31, 2027

Conditions
Phenylketonuria (PKU)
Interventions
DRUG

Pegvaliase

Pegvaliase 2.5mg/10mg/20mg/40mg/60mg self-administered from 1 time up to 7 times a week

OTHER

Diet Only

Diet Control

Trial Locations (16)

15224

University of Pittsburgh Medical Center, Pittsburgh

22903

University of Virginia School of Medicine, Charlottesville

33606

University of South Florida, Tampa

40506

University of Kentucky College of Medicine, Lexington

46202

IU Health University Hospital, Indianapolis

53226

Children's Hospital of Wisconsin, Milwaukee

60611

Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago

72202

Arkansas Children's Hospital, Little Rock

77030

McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth), Houston

80045

Children's Hospital of Colorado, Aurora

84132

University of Utah Medical Center, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

02115

Boston Children's Hospital, Boston

Unknown

Charité - Universitätsmedizin Berlin, Berlin

Universitätsklinikum Hamburg-Eppendorf, Hamburg

Universitat Mainz, Mainz

Sponsors
All Listed Sponsors
lead

BioMarin Pharmaceutical

INDUSTRY