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Gainesville, Florida 32610


Purpose:

The purpose of this study is to find out whether 4-PBA will increase the level of AAT in persons with AAT deficiency whether or not they have liver disease.


Study summary:

The purpose of this study is to determine whether 4-PBA will significantly increase serum Z AAT levels in AAT-deficient individuals with and without evidence of hepatocellular injury and to assess its effects on liver injury.


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


NCT ID:

NCT00067756


Primary Contact:

Principal Investigator
Mark L Brantly, MD
University of Florida


Backup Contact:

N/A


Location Contact:

Gainesville, Florida 32610
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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