Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency

• Status: Terminated
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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 .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH); Novartis; University of Pittsburgh
• Treatments: Alpha 1-Antitrypsin; Carbamazepine; Protein C Inhibitor

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.