Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding

Phase 3 Completed 70 enrolled Debiovision

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The main objective of this study is to determine the efficacy of early administration of Sanvar® in combination with endoscopic treatment for the control of acute variceal bleeding.

Timeline

Start: 2006-05
Primary completion: 2008-06
Completion: 2008-07

Outcome

Met primary endpoint

release “In a Phase III clinical study conducted with 227 patients in 22 centres Sanvar® IR was shown to significantly reduce active bleeding.” debiopharm.com ↗

release “Survival with hemostasis at 5 days was achieved significantly (p=0.021) more often with Sanvar® IR than with placebo.” debiopharm.com ↗

Publications

Background Cales P, Masliah C, Bernard B, Garnier PP, Silvain C, Szostak-Talbodec N, Bronowicki JP, Ribard D, Botta-Fridlund D, Hillon P, Besseghir K, Lebrec D; French Club for the Study of Portal Hypertension. Early administration of vapreotide for variceal bleeding in patients with cirrhosis. N Engl J Med. 2001 Jan 4;344(1):23-8. doi: 10.1056/NEJM200101043440104.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	vapreotide	Protein / enzyme biologic	50 ug	Intravenous