Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
BioMarin Pharmaceutical |
---|---|
Information provided by: | BioMarin Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00634660 |
The purpose of this study is to assess the safety and tolerability of injections of rAvPAL-PEG in subjects with PKU.
Condition | Intervention | Phase |
---|---|---|
Phenylketonuria |
Drug: rAvPAL-PEG |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single, Subcutaneous Doses of rAvPAL-PEG in Subjects With Phenylketonuria |
Estimated Enrollment: | 35 |
Study Start Date: | May 2008 |
Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Children's Memorial Hospital | |
Chicago, Illinois, United States, 60614 | |
United States, Minnesota | |
University of Minnesota Medical Center-Fairview | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Missouri | |
Washington University Center for Applied Research Sciences | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Mount Sinai Medical Center | |
New York, New York, United States, 10029 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Utah | |
University of Utah Hospital | |
Salt Lake City, Utah, United States, 84132 | |
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53705 |
Study Director: | Jutta Neuenburg, MD | BioMarin Pharmaceutical |
Responsible Party: | BioMarin Pharmaceutical Inc. ( BioMarin Pharmaceutical Inc. ) |
Study ID Numbers: | PAL-001 |
Study First Received: | March 6, 2008 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00634660 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metabolism, Inborn Errors Metabolic Diseases Genetic Diseases, Inborn Inborn Amino Acid Metabolism Disorder Amino Acid Metabolism, Inborn Errors Central Nervous System Diseases |
Brain Diseases, Metabolic, Inborn Phenylketonurias Brain Diseases Metabolic Disorder Phenylketonuria Brain Diseases, Metabolic |
Metabolism, Inborn Errors Metabolic Diseases Genetic Diseases, Inborn Amino Acid Metabolism, Inborn Errors Nervous System Diseases |
Central Nervous System Diseases Brain Diseases, Metabolic, Inborn Phenylketonurias Brain Diseases Brain Diseases, Metabolic |