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

This study has been completed.
Information provided by (Responsible Party):
Ferring Pharmaceuticals Identifier:
First received: April 7, 2011
Last updated: October 5, 2012
Last verified: October 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 Intervention
Gastrointestinal Bleeding Oesophageal Varices Other: Glypressin (terlipressin)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices

Resource links provided by NLM:

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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)

Enrollment: 20
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Glypressin (terlipressin)
    Study drug (without placebo)

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
60 estimated eligible participants with an age of 18-70 years, suspected or diagnosed with bleeding oesophageal varices. Patients have cirrhosis (from any cause, any Child class) and upper gastrointestinal haemorrhage

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01335516

Emergency County Hospital - Surgery Clinic No.1
Târgu Mureş, Mureş, Romania
Sponsors and Collaborators
Ferring Pharmaceuticals
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Responsible Party: Ferring Pharmaceuticals Identifier: NCT01335516     History of Changes
Other Study ID Numbers: FE999908 CS04
Study First Received: April 7, 2011
Last Updated: October 5, 2012

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Varicose Veins
Esophageal and Gastric Varices
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Hypertension, Portal
Liver Diseases
Antihypertensive Agents
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs processed this record on September 21, 2017