Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKU

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Phenylketonuria
Interventions
DRUG

rAvPAL-PEG 0.001 mg/kg

In Part 1, the planned starting dose levels is 0.001 mg/kg

DRUG

rAvPAL-PEG 0.003 mg/kg

In Part 1, the planned starting dose levels is 0.003 mg/kg

DRUG

rAvPAL-PEG 0.01 mg/kg

In Part 1, the planned starting dose levels is 0.01 mg/kg

DRUG

rAvPAL-PEG 0.03 mg/kg

In Part 1, the planned starting dose levels is 0.03 mg/kg

DRUG

rAvPAL-PEG 0.1 mg/kg

In Part 1, the planned starting dose levels is 0.1 mg/kg

Trial Locations (11)

10029

Mount Sinai School of Medicine, New York

12208

Albany Medical Center, Albany

15213

University of Pittsburgh Medical Center, Pittsburgh

30033

Emory Universty, Decatur

44308

Akron Children's Hospital, Akron

55455

University of Minnesota Medical Center-Fairview, Minneapolis

60614

Children's Memorial Hospital, Chicago

63110

Washington University Center for Applied Research Sciences, St Louis

80045

The Children's Hospital, Aurora

84132

University of Utah Hospital, Salt Lake City

97239

Oregon Health & Science University, Portland

Sponsors
All Listed Sponsors
lead

BioMarin Pharmaceutical

INDUSTRY