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

Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alpha-1-antitrypsin Deficiency; Liver Cirrhosis

Intervention: Drug-Carbamazepine (Tegretol XR) (Drug); Carbamazepine (Tegretol XR) Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
David H. Perlmutter, M.D., Principal Investigator, Affiliation: Children's Hospital of Pittsburgh,UPMC

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

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 .

Clinical Details

Official title: A Preliminary Study of the Efficacy and Safety of Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary outcome will be to determine the effect of Carbamazepine on hepatic ATZ load.

Secondary outcome:

For the secondary outcomes we will determine the effect of Carbamazepine treatment on hepatic fibrosis.

For the secondary outcome we will determine if Carbamazepine treatment reduces the MELD score.

Detailed description: 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.

Eligibility

Minimum age: 14 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

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

Children's Hospital of Pittsburgh, UPMC, Pittsburgh, Pennsylvania 15201, United States; Recruiting
David H Perlmutter, M.D., Phone: 412-692-8071, Email: David.perlmutter@chp.edu
David H. Perlmutter, M.D., Principal Investigator
Robert H. Squires, JR., M.D., Sub-Investigator
Benjamin Shneider, M.D., Sub-Investigator
Alejandro Hoberman, M.D., Sub-Investigator
Ira Bergman, M.D., PhD., Sub-Investigator
Andrew Chu, MD, Sub-Investigator

University of Pittsburgh Medical Center, Presbyterian Hospital, Pittsburgh, Pennsylvania 15213, United States; Recruiting
David H. Perlmutter, M.D., Phone: 412-692-8071, Email: David.perlmutter@chp.edu
David H. Perlmutter, M.D., Principal Investigator
George Michalopoulos, M.D., PhD., Sub-Investigator
Albert Zajko, M.D., Sub-Investigator
Kapil Chopra, M.D., Sub-Investigator

Additional Information

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

Starting date: January 2012
Last updated: December 2, 2014

Page last updated: August 23, 2015

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