Trials / Completed
CompletedNCT01335516
Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Glypressin (terlipressin) | Study drug (without placebo) |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2011-04-14
- Last updated
- 2012-10-08
Locations
1 site across 1 country: Romania
Source: ClinicalTrials.gov record NCT01335516. Inclusion in this directory is not an endorsement.