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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01335516
First Posted: April 14, 2011
Last Update Posted: October 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ferring Pharmaceuticals
  Purpose

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)
  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335516


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

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01335516     History of Changes
Other Study ID Numbers: FE999908 CS04
First Submitted: April 7, 2011
First Posted: April 14, 2011
Last Update Posted: October 8, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Hemorrhage
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
Terlipressin
Lypressin
Antihypertensive Agents
Vasoconstrictor Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs