Long-Term Extension of Previous rAvPAL-PEG Protocols in Subjects With PKU (PAL-003)

PHASE2CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

January 13, 2010

Primary Completion Date

January 31, 2019

Study Completion Date

January 31, 2019

Conditions
Phenylketonuria
Interventions
DRUG

rAvPAL-PEG

The doses are planned to be in the same range as those tested in PAL-002 or PAL-004 and then modified either by increasing or decreasing the dose, adhering to an upper limit up to 5.0 mg/kg per week or 375 mg/week, considering each subject's individual responses related to safety and efficacy.

Trial Locations (14)

10029

Mount Sinai School of Medicine, New York

12208

Albany Medical Center, Albany

15224

University of Pittsburgh Medical Center, Pittsburgh

32610

University of Florida, Gainesville

40202

University of Louisville, Kosair Charities Pediatric Clinical Research Unit, Louisville

53226

Medical College of Wisconsin, Milwaukee

60611

Ann and Robert H Lurie Children's Hospital, Chicago

63110

Washington University Center for Applied Research Sciences, St Louis

65212

University of Missouri, Columbia

68198

Nebraska Medical Center, Omaha

80045

The Children's Hospital, Aurora

84108

University of Utah Hospital, Salt Lake City

97239

Oregon Health and Science University, Portland

02115

Children's Hospital Boston, Boston

Sponsors
All Listed Sponsors
lead

BioMarin Pharmaceutical

INDUSTRY