Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices
|ClinicalTrials.gov Identifier: NCT01335516|
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : October 8, 2012
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.
|Condition or disease||Intervention/treatment|
|Gastrointestinal Bleeding Oesophageal Varices||Other: Glypressin (terlipressin)|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
- Other: Glypressin (terlipressin)
Study drug (without placebo)
- To evaluate the clinical efficacy of Glypressin: measured by rapid control of heamorrhage; reduced mortality post-haemorrhage [ Time Frame: Up to 6 months ]Vital signs (blood pressure, heart rate, and body temperature) and routine safety lab analysis
- To evaluate the safety profile of Glypressin: measured by number of patients with adverse events [ Time Frame: Up to 6 months ]
- To evaluate/monitor the ease of administration in ER [ Time Frame: Up to 6 months ]Easiness of use in ER (easy to reconstitute, easy to administer, flexible dosage)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335516
|Emergency County Hospital - Surgery Clinic No.1|
|Târgu Mureş, Mureş, Romania|
|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|