drugset / Trial / NCT06815770

Efficacy and Safety of Continuous Infusion of Terlipressin vs Bolus Terlipressin in ACLF Patients With Acute Esophageal Variceal Bleed

NCT06815770

Phase 2/3 Not yet recruiting 60 enrolled Institute of Liver and Biliary Sciences, India
RandomizedParallel-groupOpen-labelTreatment

Summary

Acute portal hypertension, as measured by rapid rise in hepatic venous pressure gradient (HVPG) can lead to further dreaded complications, including acute variceal bleeding (AVB) AVB: 6-week mortality rates of around 15-20% in patients with chronic liver disease without ACLF.The overall prevalence of UGH in cirrhotic patients with AD was 34.4% and 35.7% in patients with ACLF.AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. Medical therapy for esophageal variceal bleeding (EVB) aims to reduce the splanchnic blood flow and portal pressure. The most common vasoactive agents include terlipressin, vasopressin, somatostatin, and octreotide.

Timeline

Start
2025-02-10
Primary completion
2026-02-28
Completion
2026-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Terlipressin Peptide 1 mg Intravenous
Subject Terlipressin Peptide 4 mg Intravenous

Indications