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

Exclusion Criteria

• •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.