Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Aeglea Biotherapeutics
Age
2–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented diagnosis of Arginase I deficiency
Adequate organ function: Hgb ≥ 10 g/dL, ANC ≥ 1.5 x 109/L, plt count ≥ 100,000/µL; liver transaminase levels ≤ 2.5x ULN, total bilirubin ≤ 2.0 mg/dL; serum creatinine \<1.5 x ULN
If female and of child-bearing potential, has a negative serum pregnancy test within 7 days before enrollment
If a sexually active (male or female), must be surgically sterile, post-menopausal (female), or must agree to use a physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
Patient or legal guardian is able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures and continuation of prescribed diet without modification) prior to any screening procedures
You may not be if
Transfusion of ≥ 2 u RBC within 60 days
Active infection requiring systemic treatment
Known infection with HIV, Hep B or Hep C
Severe hyperammonemia requiring hospitalization within 14 days. Had more than one episode of hyperammonemia requiring hospitalization within the 30 days prior to enrollment.
Current uncontrolled hyperammonemia
Has a history of hypersensitivity to PEG or any other component of the AEB1102 (Co-ArgI-PEG) formulation
If female, is lactating or breast feeding
PART 2 INCLUSION CRITERION:
1\. Did not experience any safety or tolerability event in Part 1 which would preclude continued participation and dosing of AEB1102
