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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT01810458
Eligibility Criteria:
Inclusion Criteria:
* Alpha-1 Antitrypsin deficiency confirmed to be PI\*ZZ by both genotype or another identified rare allele;
* Age range from 18-70;
* Willingness to consent to liver biopsy;
* Ability to travel to UF as necessary by protocol; and
* Platelet count greater than or equal to 50,000/mm3 and an INR less than or equal to 1.5.
Exclusion Criteria:
* Hemophilia, anticoagulant therapy that cannot be interrupted briefly, malignancy, or any other condition that would compromise the safety of a liver biopsy;
* Any known pre-existing medical condition that might interfere with the patient's participation in and completion of the study or any condition, which in the opinion of the investigator would make the patient unsuitable for enrollment;
* Active substance abuse including, but not limited to, alcohol, intravenous or, inhaled drugs;
* History of adverse reactions or allergy to the local anesthetic, sedative, or pre-medication used for the percutaneous liver biopsy;
* Poor venous access making the subject unable to complete the required laboratory testing schedule; and
* Females who are pregnant or lactating at time of enrollment. Should a female subject become pregnant during the follow up period after the initial liver biopsy, continued participation would be allowed if the following conditions are met: the subject desires to continue; a discussion of risk and benefits of participation between the principal investigator and the subject has occurred; and no liver biopsy would be performed in the follow up period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01810458
Study Brief:
Protocol Section:
NCT01810458