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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01335516
First received: April 7, 2011
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate/monitor the ease of administration in ER [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01335516     History of Changes
Other Study ID Numbers: FE999908 CS04
Study First Received: April 7, 2011
Last Updated: October 5, 2012
Health Authority: Romania: National Medicines Agency

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal and Gastric Varices
Gastrointestinal Hemorrhage
Hemorrhage
Varicose Veins
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Terlipressin
 Lypressin
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013