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Hemodynamic Effects of Terlipressin vs High Dose Octreotide in Cirrhosis
NCT02119884Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2014
- Primary completion
- Jun 2016
- Countries
- 1
- Sponsor
- Zhongshan Hospital, Fudan University
- Modality
- Peptides, Small Molecules
- Conditions
- esophageal varicesgastric varices
01
Overview
Phase 4, randomised, single-blind trial of terlipressin and Octreotide long-acting injection in esophageal varices and gastric varices (2 arms), sponsored by Zhongshan Hospital, Fudan University. Primary endpoint: Fluctuation of Hepatic Venous Pressure Gradient. Started Feb 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Terlipressin Group
Terlipressin 2 mg IV bolus + Normal Saline infusion
High Dose Octreotide Group
Octreotide 100 mcg bolus + 50 mcg/h infusion
03
Who it enrols
Adult patients (18-80 years) with cirrhosis and confirmed gastric/esophageal varices who have experienced variceal bleeding. Excludes patients with unstable vital signs, severe infections, hepatorenal syndrome, renal inadequacy, or uncontrolled hepatic encephalopathy.
04
Endpoints
Primary
Fluctuation of Hepatic Venous Pressure Gradient
Secondary
Hemodynamic Response Rate
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