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Carbamazepine in Alpha-1 Antitrypsin Deficiency Liver Disease
NCT01379469Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2012
- Primary completion
- Feb 2017
- Countries
- 1
- Sponsor
- Washington University School of Medicine
- Drugs
- carbamazepine
- Conditions
- alpha-1 antitrypsin deficiency (AATD)
01
Overview
Phase 2, randomised, double-blind trial of carbamazepine in alpha-1 antitrypsin deficiency (AATD), sponsored by Washington University School of Medicine. Primary endpoint: Hepatic ATZ Load at 52 weeks. Started Jan 2012; status: terminated.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Patients aged 14-80 with ZZ or SZ phenotype alpha-1 antitrypsin deficiency, low serum levels, and portal hypertension (HVPG >= 10 mmHg), excluding those with very severe liver failure (Child-Pugh >= 12).
04
Endpoints
Primary
Hepatic ATZ Load
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