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

NCT01335516 | Completed

• 1 other identifier: FE999908 CS04
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Bleeding; Oesophageal Varices

Outcome Measures

Primary Outcomes (2)

• To evaluate the clinical efficacy of Glypressin: measured by rapid control of heamorrhage; reduced mortality post-haemorrhage

  Vital signs (blood pressure, heart rate, and body temperature) and routine safety lab analysis

  Up to 6 months

• To evaluate the safety profile of Glypressin: measured by number of patients with adverse events

  Up to 6 months

Secondary Outcomes (1)

• To evaluate/monitor the ease of administration in ER

  Up to 6 months

Interventions

Glypressin (terlipressin) OTHER

Study drug (without placebo)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Emergency County Hospital - Surgery Clinic No.1

Târgu Mureş, Mureș County, Romania

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Esophageal and Gastric Varices

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Hypertension, Portal; Liver Diseases

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 14, 2011
• Study Start: November 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 8, 2012

Record last verified: 2012-10

Locations

RO (1)