drugset / Trial / NCT04028505

Terlipressin Infusion in Variceal Hemorrhage

NCT04028505

Phase 3 Unknown 128 enrolled Aga Khan University Mallinckrodt · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Randomized, open label study of intravenous terlipressin infusion vs. bolus for the treatment of variceal hemorrhage. 24 hour regimen consisting of intravenous terlipressin will be used either at a rate of 0.5mg/hour or 2mg bolus every 4 hourly. Participants will be randomized into intervention and control arm using block randomization by computer generated random numbers. Efficacy will be assessed by clinical improvement in symptoms and signs of GI bleed. To assess safety, frequency and degree of adverse reactions will be observed. Periodic assessments until 5 days will be done consisting of physical examination, safety assessments, vital signs and lab tests.

Timeline

Start
2018-10-25
Primary completion
2020-04-25
Completion
2020-10-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Terlipressin Peptide 0.5 mg Intravenous
Subject Terlipressin Peptide 2 mg Intravenous

Indications

No indication recorded.