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



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:14 - 80
Updated:5/19/2018
Start Date:January 2012
End Date:January 2020
Contact:Adam D Kufen, RN, BS, CCRC
Email:adam.kufen@chp.edu
Phone:412-692-6558

Use our guide to learn which trials are right for you!

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

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 .

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.

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.
We found this trial at
3
sites
Pittsburgh, Pennsylvania 15213
Principal Investigator: Robert H. Squires, M.D.
Phone: 412-692-7506
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Robert H. Squires, JR., M.D.
Phone: 412-692-7506
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Principal Investigator: David A Rudnick, MD, PhD
Phone: 3147471217
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials