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

PHASE2TerminatedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

February 28, 2017

Study Completion Date

February 28, 2017

Conditions
Alpha-1-antitrypsin DeficiencyLiver Cirrhosis
Interventions
DRUG

Drug-Carbamazepine (Tegretol XR)

To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated..

DRUG

Carbamazepine (Tegretol XR) Placebo

Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine.

Trial Locations (3)

15201

Children's Hospital of Pittsburgh, UPMC, Pittsburgh

15213

University of Pittsburgh Medical Center, Presbyterian Hospital, Pittsburgh

63110

Washington University in St. Louis School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

University of Pittsburgh

OTHER

lead

Washington University School of Medicine

OTHER