Pegtibatinase As an Enzyme Therapy for Patients with Homocystinuria Caused by Cystathionine Beta-Synthase Deficiency (COMPOSE)

Exclusion Criteria

• •Previous exposure to pegtibatinase and/or previous participation in a clinical trial that included administration of pegtibatinase
• •Use of any investigational product or investigational medical device within 30 days prior to Screening, or while on study
• •Use or planned use of any injectable drugs containing PEG (other than pegtibatinase or COVID-19 vaccines), including medroxyprogesterone (eg, Depo-Provera) injection, within 3 months prior to Screening and during study participation
• •Known hypersensitivity to PEG-containing product or any components of pegtibatinase
• •A positive test for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody
• •A history of organ transplantation, chronic immunosuppressive therapy, or substance abuse
• •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 or planned major surgery that would interfere with study participation or safety in the opinion of the investigator.
• •Any condition that, in the view of the investigator, places the subject at high risk of poor treatment compliance or of not completing the study
• •Major surgery planned during the study period