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

Completed

• Conditions: Gastrointestinal Bleeding; Oesophageal Varices

• Registration Number: NCT01335516
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-05
• Last Update Posted: 2012-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Eligible patients that present an important upper gastrointestinal bleeding, being suspected or diagnosed of liver cirrhosis, with bleeding oesophageal varices visualized endoscopically.

(An important upper gastrointestinal bleeding is one requiring at least 2 units/24h of transfused blood).

Exclusion Criteria

• Septic shock
• Patients with recent history of coronary insufficiency
• Uncontrolled arterial hypertension
• Chronic respiratory failure
• Symptomatic arteritis
• Chronic renal failure
• Pregnant women
• Hypersensitivity to terlipressin
• Patients with body weight below 55 kg

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the clinical efficacy of Glypressin: measured by rapid control of heamorrhage; reduced mortality post-haemorrhage	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	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
To evaluate/monitor the ease of administration in ER	Up to 6 months	Easiness of use in ER (easy to reconstitute, easy to administer, flexible dosage)

Trial Locations

Locations (1)

Emergency County Hospital - Surgery Clinic No.1; 🇷🇴 Târgu Mureş, Mureş, Romania