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Gabexate Mesilate for Hepatocyte Protection After Liver Resection
NCT02710266Phase 3
Key facts
- Status
- Terminated
- Start
- Feb 2012
- Primary completion
- Feb 2017
- Countries
- 1
- Sponsor
- Yonsei University
- Drugs
- gabexate
- Conditions
- liver failure
01
Overview
Phase 3, randomised, double-blind trial of gabexate in liver failure (3 arms), sponsored by Yonsei University. Primary endpoint: Postoperative complications at 30 days. Started Feb 2012; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Placebo group
Hepatectomy with 5% dextrose water placebo
Preoperative Gabexate Mesilate group
Gabexate Mesilate starting 1 day before surgery
Intraoperative Gabexate Mesilate group
Gabexate Mesilate starting on the day of surgery
03
Who it enrols
Patients aged 20-80 with liver tumors requiring resection of more than two segments, with good performance status (Karnofsky > 70% or ECOG 0-1) and no history of hepatic duct reconstruction or high anesthetic risk (ASA >= 3).
04
Endpoints
Primary
Postoperative complications
Secondary
Liver function recovery time
Length of hospitalization
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