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

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ClinicalTrials.gov Identifier: NCT01335516
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Gastrointestinal Bleeding Oesophageal Varices Other: Glypressin (terlipressin)

Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices
Study Start Date : November 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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

  2. To evaluate the safety profile of Glypressin: measured by number of patients with adverse events [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01335516     History of Changes
Other Study ID Numbers: FE999908 CS04
First Posted: April 14, 2011    Key Record Dates
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