Gastrointestinal BleedingNCT01335516
Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices
An observational study of Gastrointestinal Bleeding and Oesophageal Varices, run by Ferring Pharmaceuticals at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Bleeding, Oesophageal Varices
- What is being tested?
- Glypressin (terlipressin)
- How many people
- 20 participants
- Where
- 1 siteRomania
- Study dates
- Nov 2010to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- Septic shock
- Patients with recent history of coronary insufficiency
- Uncontrolled arterial hypertension
- Chronic respiratory failure
- Symptomatic arteritis
- Chronic renal failure
Show all 9Show fewer
- Pregnant women
- Hypersensitivity to terlipressin
- Patients with body weight below 55 kg
Trial locations and contacts
1 site in 1 country.
Romania1 site
Emergency County Hospital - Surgery Clinic No.1
Târgu Mureş, Mureș County
About this study
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%.
Read more
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
- Being tested
- Glypressin (terlipressin)
- Medical subject headings
- Gastrointestinal Hemorrhage, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glypressin (terlipressin)Other
Study drug (without placebo)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 months
To evaluate the safety profile of Glypressin: measured by number of patients with adverse events
Measured: Up to 6 months
Secondary outcomes (1)
To evaluate/monitor the ease of administration in ER
Easiness of use in ER (easy to reconstitute, easy to administer, flexible dosage)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startNov 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335516
- Sponsor's protocol ID
- FE999908 CS04
- Status last verified
- Oct 2012
- First submitted
- 7 Apr 2011
- Last updated
- 8 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices
- ClinicalTrials.gov ID
- NCT01335516
- Acronym / sponsor ID
- FE999908 CS04
- Conditions
- Gastrointestinal Bleeding, Oesophageal Varices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (9 listed)
- Septic shock
- Patients with recent history of coronary insufficiency
- Uncontrolled arterial hypertension
- Chronic respiratory failure
- Symptomatic arteritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glypressin (terlipressin)Study drug (without placebo) | Other | – |
Primary outcome
To evaluate the clinical efficacy of Glypressin: measured by rapid control of heamorrhage; reduced mortality post-haemorrhage
Time frame: Up to 6 months
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
1 secondary outcome
To evaluate/monitor the ease of administration in ER
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Bleeding and Oesophageal Varices, run by Ferring Pharmaceuticals at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2012.