Liver Fibrosis Clinical Trial
Official title:
Clinical Predictors and Epigenetic Markers for Liver Fibrosis in Alpha-1 Antitrypsin Deficiency
Verified date | August 2023 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 109 |
Est. completion date | September 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Shands at the University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To estimate the prevalence and histologic spectrum of liver injury in an adult with Alpha-1 Antitrypsin deficiency having a ZZ genotype or other rare allele. | An abdominal ultrasound will be done at the screening visit. A liver biopsy will be done on subjects who pass the screening process. The biopsy will be done within 30 days of the screening visit. | up to 30 days | |
Secondary | To identify environmental and host risk factors for clinically significant liver fibrosis. | A liver disease questionnaire will be done at the time of the first liver biopsy and at the year 3 study visit. A history and physical will also be completed at the screening visit, year 1 visit, year 2 visit, and year 3 visit. | At each study visit including screening, first liver biopsy, year 1, year 2, and year 3 visits. | |
Secondary | To define the diagnostic accuracy of non-invasive markers of fibrosis in AAT liver disease. | An abdominal ultrasound will be completed at the screening visit and the year 3 visit. | At the screening and year 3 visits. | |
Secondary | To explore epigenetic markers for the development of liver fibrosis. | Liver tissue collected at the time of the first biopsy will be sent for testing which will evaluate for epigenetic markers of liver fibrosis. For subjects whose initial liver biopsy reveals liver fibrosis between stages 2 - 4, additional liver tissue will be collected at the time of the repeat biopsy done at the year 3 study visit. | Starting with the first liver biopsy and ending with the second liver biopsy done at year 3. | |
Secondary | To quantify liver fibrosis progression. | The presence and progression of liver fibrosis will be evaluated by an abdominal ultrasound done at the screening visit, year 1 visit, year 2 visit, and year 3 visit. A liver biopsy will be done if a subject passes the screening visit and will be repeated at the year 3 study visit if the initial liver biopsy reveals liver fibrosis between stages 2 - 4. | At each study visit including screening, first liver biopsy, year 1, year 2, and year 3 visits. |
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