This study is an extension of previous rAvPAL-PEG studies. Administration of rAvPAL-PEG will
be continued to assess whether long-term dosing of rAvPAL-PEG is safe and can maintain
reduced blood Phe concentrations in PKU subjects.
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT00924703
Ages eligible for Study
16 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
Must have completed participation in previous rAvPAL-PEG studies.
Willing and able to provide written, signed informed consent, or, in the case of participants under the age of 18, provide written assent (if required) and written informed consent by a parent or legal guardian, after the nature of the study has been explained, and prior to any research-related procedures.
Willing and able to comply with all study procedures.
Females of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or had tubal ligation at least 1 year prior to Screening, or who have had total hysterectomy.
Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study.
Maintained a stable diet.
In generally good health as evidenced by physical examination, clinical laboratory evaluations (hematology, chemistry, and urinalysis), and electrocardiogram (ECG) at Screening.
Use of any investigational product (with the exception of rAvPAL-PEG) or investigational medical device within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
Use of any medication that is intended to treat PKU within 14 days prior to the administration of study drug.
Use or planned use of any injectable drugs containing PEG (other than rAvPAL-PEG), including Depo-Provera during study participation.
A prior reaction that included systemic symptoms (eg, generalized hives, respiratory or gastrointestinal problems, hypotension, angioedema, anaphylaxis) to rAvPAL-PEG or a PEG-containing product.
Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) or to breastfeed at any time during the study.Concurrent disease or condition that would interfere with study participation or safety (eg, history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, oncologic, or psychiatric disease).
Any condition that, in the view of the PI, places the subject at high risk of poor treatment compliance or of not completing the study.
Known hypersensitivity to rAvPAL-PEG or its excipients, including hypersensitivity reactions that necessitated early termination from previous rAvPAL-PEG studies.
Alanine aminotransferase (ALT) concentration > 2 times the upper limit of normal.
Creatinine > 1.5 times the upper limit of normal.
All locations for NCT00924703
United States (14)
The Children's Hospital
Aurora, Colorado, United States, 80045
University of Florida
Gainesville, Florida, United States, 32610
Ann and Robert H Lurie Children's Hospital
Chicago, Illinois, United States, 60614
University of Louisville, Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States, 40202
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
University of Missouri
Columbia, Missouri, United States, 65201
Washington University Center for Applied Research Sciences
St. Louis, Missouri, United States, 63110
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Albany Medical Center
Albany, New York, United States, 12208
Mount Sinai School of Medicine
New York, New York, United States, 10029
Oregon Health and Science University
Portland, Oregon, United States, 97239
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
View full eligibility
Tris trial is registered with FDA with number: NCT00924703. The sponsor of the trial is BioMarin Pharmaceutical and it is looking for 68 volunteers for the current phase.
Official trial title: Long-term Extension of a Phase 2, Open-Label Dose-Finding Study to Evaluate the Safety, Efficacy, and Tolerability of Multiple Subcutaneous Doses of rAvPAL-PEG in Subjects With PKU
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