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

Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335516
• Other study ID #: FE999908 CS04
• Status: Completed
• Phase: N/A
• First received: April 7, 2011
• Last updated: October 5, 2012
• Start date: November 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage
• Oesophageal Varices

Intervention

Other:
• Glypressin (terlipressin)
Study drug (without placebo)

Locations

Country	Name	City	State
Romania	Emergency County Hospital - Surgery Clinic No.1	Târgu Mures	Mures

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the clinical efficacy of Glypressin: measured by rapid control of heamorrhage; reduced mortality post-haemorrhage	Vital signs (blood pressure, heart rate, and body temperature) and routine safety lab analysis	Up to 6 months	No
Primary	To evaluate the safety profile of Glypressin: measured by number of patients with adverse events		Up to 6 months	No
Secondary	To evaluate/monitor the ease of administration in ER	Easiness of use in ER (easy to reconstitute, easy to administer, flexible dosage)	Up to 6 months	No