Clinical Trials Directory

Trials / Completed

CompletedNCT01335516

Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

Terlipressin is an effective and safe treatment for bleeding caused by rupture of oesophageal varices, which are life-threatening complications of liver cirrhosis. Oesophageal varices are abnormal dilatation of veins occurring in the lower oesophagus, which can develop in patients with cirrhosis. Bleeding caused by rupture of these varices is a life-threatening complication with mortality between 20-50%. Such bleeding can be treated with drug therapy and/or endoscopic; endoscopic therapy consists of a flexible tube equipped with a camera at the terminal end, allowing for visualizing and treating the oesophageal varices. In this study, investigators will evaluate the safety and efficacy of terlipressin - Glypressin 1 mg, powder and solvent for solution for injection. The non-interventional observational study "Follow-up of Glypressin (terlipressin) clinical efficacy in the treatment of bleeding oesophageal varices" aims to demonstrate that administration of Glypressin (terlipressin 1 mg) controls the bleeding in such patients.

Conditions

Interventions

TypeNameDescription
OTHERGlypressin (terlipressin)Study drug (without placebo)

Timeline

Start date
2010-11-01
Primary completion
2011-08-01
Completion
2011-08-01
First posted
2011-04-14
Last updated
2012-10-08

Locations

1 site across 1 country: Romania

Source: ClinicalTrials.gov record NCT01335516. Inclusion in this directory is not an endorsement.