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

April 7, 2011
October 5, 2012
November 2010
August 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01335516 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices
Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Gastrointestinal Bleeding
  • Oesophageal Varices
Other: Glypressin (terlipressin)
Study drug (without placebo)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT01335516
FE999908 CS04
No
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP