CirrhosisPhase 4NCT00287664
Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin
A Phase 4 study testing terlipressin in people with Cirrhosis and Hepatorenal Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin are effective in the reversal of the treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Hepatorenal Syndrome
- What is being tested?
- terlipressin
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2002to Sep 2006
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with HRS type 1 or 2 with serum creatinine >2 mg/dL
- Age between 18 and 75 years
- Written informed consent.
- Absence of exclusion criteria
Who cannot join
- Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule > than 5 cm)
- Active infection with systemic inflammatory response syndrome
- Respiratory or cardiac dysfunction.
- Arteriopathy.
- Ischemic cardiopathy.
- Arterial hypertension ( >140/90 mmHg during hospitalization )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study
Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin are effective in the reversal of the treatment. However, previous studies are pilot studies and they are not able to give information about an improvement in survival. This comparative randomized study was delineated to test the efficacy of terlipressin on survival.
Read the detailed description
Phase 3
- Conditions
- Cirrhosis, Hepatorenal Syndrome
- Being tested
- terlipressin
- Keywords
- hepatorenal syndrome, terlipressin, albumin, cirrhosis
- Medical subject headings
- Fibrosis, Hepatorenal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terlipressinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startFeb 2002
- Study completionSep 2006
Why it stopped: because in a preliminary analysis we would need 1000 patients per group to achieve significative differences in the main end point.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Grant from Education Ministery from 2001-2004.
- Investigators
- Pere Gines, MD, Principal investigator, Chair of Liver Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287664
- Sponsor's protocol ID
- TAHRS
- Status last verified
- Apr 2007
- First submitted
- 3 Feb 2006
- Last updated
- 11 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study
- ClinicalTrials.gov ID
- NCT00287664
- Acronym / sponsor ID
- TAHRS
- Conditions
- Cirrhosis, Hepatorenal Syndrome
- Keywords
- hepatorenal syndrome, terlipressin, albumin, cirrhosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: because in a preliminary analysis we would need 1000 patients per group to achieve significative differences in the main end point.
- Enrolment
- 100 participants
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Grant from Education Ministery from 2001-2004.
- Study start
- Feb 2002
- Study completion
- Sep 2006
- First posted
- 7 Feb 2006 (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.
Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin are effective in the reversal of the treatment. However, previous studies are pilot studies and they are not able to give information about an improvement in survival. This comparative randomized study was delineated to test the efficacy of terlipressin on survival.
Detailed description
Phase 3
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with HRS type 1 or 2 with serum creatinine >2 mg/dL
- Age between 18 and 75 years
- Written informed consent.
- Absence of exclusion criteria
Key exclusion criteria (6 listed)
- Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule > than 5 cm)
- Active infection with systemic inflammatory response syndrome
- Respiratory or cardiac dysfunction.
- Arteriopathy.
- Ischemic cardiopathy.
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 |
|---|---|---|
| terlipressin | Drug | – |
Primary outcome
Survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2007.
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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.
Pere Gines, MD principal investigator
Chair of Liver Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing terlipressin in people with Cirrhosis and Hepatorenal Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 4 inclusion and 6 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: paused, as of the sponsor's last update on 11 Apr 2007. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Survival. 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 11 Apr 2007.