Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (Liver AATD)
Completed
Conditions studied: Liver Fibrosis, Alpha-1 Antitrypsin Deficiency, AAT Deficiency, AATD
In brief
We hypothesize that individuals with Alpha-1 Antitrypsin (AAT) deficiency have ongoing liver injury which is not detected by the usual blood tests used to look at liver function. This ongoing liver injury leads to cirrhosis in a significant number of adults with AAT deficiency.
Key facts
- Study ID
- NCT01810458
- Run by
- University of Florida
- People needed
- 109
- Starts
- 2013-10-01
- Expected to finish
- 2019-09-01
- Last updated by the study team
- 2023-08-21
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Shands at the University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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