Saint Louis, Missouri 63110

  • Liver Cirrhosis

Purpose:

The primary objective is to determine if the medication Carbamazepine, can be used as a therapy for patients with severe liver disease due to Alpha-1-Antitrypsin Deficiency .


Study summary:

The primary objective is to determine if Carbamazepine therapy in patients with severe liver disease due to Alpha-1-Antitrypsin Deficiency leads to a significant reduction in the hepatic accumulation of ATZ. The other objectives are: To determine whether Carbamazepine treatment reduces hepatic fibrosis in alpha-1-antitrypsin deficient patients with severe liver disease. To determine whether Carbamazepine treatment reduces portal pressure in alpha-1-antitrypsin deficient patients with severe liver disease. To determine whether Carbamazepine treatment is safe and tolerated by patients with severe liver disease caused by alpha-1-deficiency. To determine whether Carbamazepine treatment leads to stabilization in disease severity as measured by the MELD scores.


Criteria:

Inclusion Criteria: - Age greater than or equal to 14 years to less than or equal to 80 years of age. - Alpha-1-Antitrypsin deficiency confirmed by ZZ or SZ phenotype & serum level - < 83mg/dl. - HVPG greater than or equal to 10 mmHg unless collateral vessels are visualized via transvenous biopsy. Exclusion Criteria: - Child Pugh Score greater than or equal to 12. Serum total bilirubin > 5 mg/dl. INR > 2.2.


NCT ID:

NCT01379469


Primary Contact:

Principal Investigator
David H. Perlmutter, M.D.
Washington University School of Medicine

Adam D Kufen, RN, BS, CCRC
Phone: 412-692-6558
Email: adam.kufen@chp.edu


Backup Contact:

Email: arbt@wustl.edu
Teresa Arb, RN, BSN, CCRC
Phone: 314-747-1217


Location Contact:

Saint Louis, Missouri 63110
United States

Teresa Arb, RN, BSN, CCRC
Phone: 3147471217
Email: arbt@wustl.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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