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:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT01140451
Eligibility Criteria:
Inclusion Criteria:
* Completion of blinded study drug treatment in the previous Phase 3 study (PTC124-GD-009-CF).
* Ability to provide written informed consent (parental/guardian consent if applicable)/assent (if \<18 years of age).
* In participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during ataluren administration and the 4-week follow up period.
* Willingness and ability to comply with scheduled visits, drug administration plan, study procedures, laboratory tests, and study restrictions.
Exclusion Criteria:
* Known hypersensitivity to any of the ingredients or excipients of the study drug (list provided at study sites).
* Current pregnancy or lactating, or pregnancy or lactating during the previous Phase 3 study.
* Ongoing participation in any other therapeutic clinical trial.
* Prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow up would be completed, or could impair the assessment of study results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT01140451
Study Brief:
Protocol Section:
NCT01140451