Hepatorenal SyndromePhase 4NCT02489864
The Effect of Terlipressin in the Prevention of Type 2 Hepatorenal Syndrome by Improving Mean Arterial Pressure
A Phase 4 study testing Terlipressin in people with Hepatorenal Syndrome, run by Sun Yat-sen University at 1 site in China.
Trial summary
Appreciation of the central role for arterial vasodilatation in the pathogenesis of hepatorenal syndrome (HRS) has led to routine use of vasoconstrictors in combination with albumin as a medical therapy for HRS. Terlipressin have been explored but the optimal approach for such therapies has not yet been established. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatorenal Syndrome
- What is being tested?
- Terlipressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Dec 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cirrhosis as diagnosedby liver biopsy or clinical, biochemical, ultrasound,and/or endoscopic findings;
- type 2 HRS with a MAP decrees for at least 10mmHg compared to basal blood pressure ;
- age 18 to65 years;
- absence of severe bacterial infection associated with findings of systemic inflammatory response as diagnosedby the presence of at least 2 of the following criteria: body temperature <36°C or >38°C, heart rate >90 beats/min, respiration rate>20/min, and white-cell count <4 or >12 X106/L or >6% of band forms; patients with bacterial infections, however, could be included in the study if renal failure persisted after infection resolution;
- the absence of cardiovascular diseases and any extra hepatic disease that could affect the short-term prognosis;
- the absence of findings suggestive of organic nephropathy;
- the absence of advanced hepatocellularcarcinoma.
Who cannot join
- Patients with history of coronary artery disease
- Cardiomyopathy
- Ventricular arrhythmia
- Obstructive arterial disease of limbs -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Chan Xie, Dr., 8602085252372, happyxiechan@hotmail.com
About this study
Appreciation of the central role for arterial vasodilatation in the pathogenesis of hepatorenal syndrome (HRS) has led to routine use of vasoconstrictors in combination with albumin as a medical therapy for HRS. Terlipressin have been explored but the optimal approach for such therapies has not yet been established. As compared with albumin, treatment with terlipressin and albumin is effective in improving renal function in patients with cirrhosis and hepatorenal syndrome. Our previous study showed that mean arterial pressure (MAP) is a predictor of hepatorenal syndrome occurrence in cirrhotic patients with ascites. The purpose of this study was to examine the role of targeting an early and substantial increase in mean arterial pressure in the prevention of type 2 HRS.
- Conditions
- Hepatorenal Syndrome
- Being tested
- Terlipressin
- Keywords
- Terlipressin, mean arterial pressure, type 2 HRS
- Medical subject headings
- Hepatorenal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin and albumin | Active comparator | Patients in this group received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour.
albumin (Albumin 20 percent; Instituto Grífols, Barcelona, Spain) was given at a dose of 10 gram per day. Receives: Drug: Terlipressin |
| Albumin | Placebo comparator | Only albumin (Albumin 20 percent; Instituto Grífols, Barcelona, Spain) was given at a dose of 10 gram per day. Receives: Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRS incidence rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatorenal SyndromeStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan Xie, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489864
- Sponsor's protocol ID
- 2005004
- Status last verified
- Jul 2015
- First submitted
- 1 Jul 2015
- Last updated
- 3 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Terlipressin in the Prevention of Type 2 Hepatorenal Syndrome by Improving Mean Arterial Pressure
- ClinicalTrials.gov ID
- NCT02489864
- Acronym / sponsor ID
- 2005004
- Conditions
- Hepatorenal Syndrome
- Keywords
- Terlipressin, mean arterial pressure, type 2 HRS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Jul 2015 (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.
Appreciation of the central role for arterial vasodilatation in the pathogenesis of hepatorenal syndrome (HRS) has led to routine use of vasoconstrictors in combination with albumin as a medical therapy for HRS. Terlipressin have been explored but the optimal approach for such therapies has not yet been established. As compared with albumin, treatment with terlipressin and albumin is effective in improving renal function in patients with cirrhosis and hepatorenal syndrome. Our previous study showed that mean arterial pressure (MAP) is a predictor of hepatorenal syndrome occurrence in cirrhotic patients with ascites. The purpose of this study was to examine the role of targeting an early and substantial increase in mean arterial pressure in the prevention of type 2 HRS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terlipressin and albumin | Active comparator | Drug: TerlipressinPatients in this group received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour. albumin (Albumin 20 percent; Instituto Grífols, Barcelona, Spain) was given at a dose of 10 gram per day. |
| Albumin | Placebo comparator | Drug: TerlipressinOnly albumin (Albumin 20 percent; Instituto Grífols, Barcelona, Spain) was given at a dose of 10 gram per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- cirrhosis as diagnosedby liver biopsy or clinical, biochemical, ultrasound,and/or endoscopic findings;
- type 2 HRS with a MAP decrees for at least 10mmHg compared to basal blood pressure ;
- age 18 to65 years;
- absence of severe bacterial infection associated with findings of systemic inflammatory response as diagnosedby the presence of at least 2 of the following criteria: body temperature <36°C or >38°C, heart rate >90 beats/min, respiration rate>20/min, and white-cell count <4 or >12 X106/L or >6% of band forms; patients with bacterial infections, however, could be included in the study if renal failure persisted after infection resolution;
- the absence of cardiovascular diseases and any extra hepatic disease that could affect the short-term prognosis;
Key exclusion criteria (4 listed)
- Patients with history of coronary artery disease
- Cardiomyopathy
- Ventricular arrhythmia
- Obstructive arterial disease of limbs -
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 | Albumin, Terlipressin and albumin |
Primary outcome
HRS incidence rate
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
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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.
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 Hepatorenal Syndrome, run by Sun Yat-sen University at 1 site in China.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Jul 2015. 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 China. 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. Some participants in this study may receive a placebo. 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?
Contact Chan Xie, Dr. (8602085252372, happyxiechan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRS incidence rate (time frame: one year). 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 3 Jul 2015.