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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT00067756
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65
* Serum A1-PI levels \<11uM an appropriate genetic phenotype/genotype
* 5 of 10 subjects must have documented laboratory evidence of liver disease
* Willingness to withhold Prolastin therapy for 6 weeks prior to screening and throughout the 4-PBA dosing period (up to 3 months)
Exclusion Criteria:
* Any cause of liver disease other than Alpha-1 Antitrypsin deficiency
* Evidence of advanced liver disease
* HIV positive
* Use of systemic steroids, ursodeoxycholic acid (Actigall, Urso), or herbs in the prior 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00067756
Study Brief:
Protocol Section:
NCT00067756