Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glypressin (terlipressin) | Other | Study drug (without placebo) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate/monitor the ease of administration in ER | Easiness of use in ER (easy to reconstitute, easy to administer, flexible dosage) | Up to 6 months |
Not provided
Inclusion Criteria:
(An important upper gastrointestinal bleeding is one requiring at least 2 units/24h of transfused blood).
Exclusion Criteria:
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency County Hospital - Surgery Clinic No.1 | Târgu Mureş | Mureș County | Romania |
Not provided
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D004932 | Esophageal and Gastric Varices |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D006975 | Hypertension, Portal |
| D008107 | Liver Diseases |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |