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

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.

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Key information

Conditions

Gastrointestinal Bleeding Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Hypertension, Portal Liver Diseases Oesophageal Varices Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency County Hospital - Surgery Clinic No.1

Târgu Mureş, Mureș County, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glypressin (terlipressin)

Other

Study drug (without placebo)

Primary outcomes

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

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 14, 2011
Registry last updated: Oct 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed