Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2025-12-25 @ 12:29 AM
NCT ID:
NCT04480567
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects with diagnosis of PKU which is a condition characterized by PAH deficiency
* Ability and willingness to maintain dietary protein intake consistent with baseline intake
* Willingness to abstain from hepatotoxic substances post-BMN 307 administration
* Willingness and capable per investigator opinion to comply with study procedures and requirements
* Willingness to use effective methods of contraception
* Plasma Phe levels \> 600 µmol/L
Exclusion Criteria:
* Subjects with primary BH4 deficiency or other forms of BH4 metabolism deficiency
* Clinically significant liver dysfunction or disease
* Prior treatment with gene therapy
* Any condition that, in the opinion of the investigator or Sponsor, would prevent the subject from fully complying with the requirements of the study
* History of malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT04480567
Study Brief:
Protocol Section:
NCT04480567