CirrhosisPhase 4AMELIORATENCT01530711
Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response
A Phase 4 study testing Terlipressin and albumin in people with Cirrhosis and Hepatorenal Syndrome Type I, run by Pere Gines at 6 sites in Spain.
Trial summary
Observe the effect of terlipressin on renal function in patients with SHR type I adjusting the dose based on hemodynamic response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Hepatorenal Syndrome Type I
- What is being tested?
- Terlipressin and albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesSpain
- Study dates
- Apr 2012to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hepatorenal syndrome type 1.
- Signed informed consent.
- No exclusion criteria.
- At least 18 years old
- Negative pregnancy test in serum or urine in women of childbearing age, and agree to use adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last.
Who cannot join
- Hepatocellular carcinoma: exclusion of patients with hepatocellular carcinoma who present more than 3 nodules, single nodule larger than 5 cm, tumor portal thrombosis or extrahepatic tumor spread.
- Active bacterial infection with symptoms of systemic inflammatory response (fever, tachycardia, tachypnea, hypotension, septic or blood count).
- Cardiac or respiratory failure clinically significant.
- Clinically significant peripheral artery disease.
- A history of ischemic heart disease.
- Hypersensitivity to terlipressin and / or albumin or any of the excipients.
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- Pregnancy.
- Septic shock.
- Chronic renal failure.
- Women in lactation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, 08036
Hospital del Mar
Barcelona, Barcelona, 08036
Hospital Vall d´Hebron
Barcelona, Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208
Hospital Moisés Broggi
Sant Joan Despí, Barcelona, 08970
About this study
Observe the effect of terlipressin on renal function in patients with SHR type I adjusting the dose based on hemodynamic response.
- Conditions
- Cirrhosis, Hepatorenal Syndrome Type I
- Being tested
- Terlipressin and albumin
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terlipressin and albuminDrug
Terlipressin dose: 2mg/24h, it will be modified depending on: Arterial pressure increase < 10 mmHg and the creatinine values decrease <25%, it will be increased every 8 hours until reaching an increase of at least 10mmHg arterial pressure or a creatinine decrease of the 25%.
Albumin: Initial dose (first day) of 1g/Kg (up to a maximum of 100g) and the following days from 20 to 40 g/day.
| Study group | Role | What they receive |
|---|---|---|
| terlipressin | Experimental | Not described Receives: Drug: Terlipressin and albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in arterial pressure and creatinine
Measured: 4 months
Secondary outcomes (3)
Changes in plasmatic renin activity and aldosterone and noradrenaline concentration.
Measured: 4 months
Treatment-related adverse events
Measured: 4 months
Hepatorenal Syndrome reversion due to hemodynamic changes.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pere Gines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pere Gines, Hospital Clinic of Barcelona
- Investigators
- German Soriano Pastor, MD, Principal investigator, gsoriano@santpau.catJuan Cordoba, MD, Principal investigator, jcordoba@vhebron.netIsabel Cirera Lorenzo, MD, Principal investigator, ICirera@parcdesalutmar.catMarta Martín Llahí, MD, Principal investigator, martinllahi@gmail.comJordi Sánchez Delgado, MD, Principal investigator, jsanchezd@tauli.cat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530711
- Sponsor's protocol ID
- AMELIORATE
- Acronym
- AMELIORATE
- Status last verified
- Aug 2016
- First submitted
- 9 Feb 2012
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response
- ClinicalTrials.gov ID
- NCT01530711
- Acronym / sponsor ID
- AMELIORATE / AMELIORATE
- Conditions
- Cirrhosis, Hepatorenal Syndrome Type I
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pere GinesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Feb 2012 (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.
Observe the effect of terlipressin on renal function in patients with SHR type I adjusting the dose based on hemodynamic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| terlipressin | Experimental | Drug: Terlipressin and albumin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with hepatorenal syndrome type 1.
- Signed informed consent.
- No exclusion criteria.
- At least 18 years old
- Negative pregnancy test in serum or urine in women of childbearing age, and agree to use adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last.
Key exclusion criteria (10 listed)
- Hepatocellular carcinoma: exclusion of patients with hepatocellular carcinoma who present more than 3 nodules, single nodule larger than 5 cm, tumor portal thrombosis or extrahepatic tumor spread.
- Active bacterial infection with symptoms of systemic inflammatory response (fever, tachycardia, tachypnea, hypotension, septic or blood count).
- Cardiac or respiratory failure clinically significant.
- Clinically significant peripheral artery disease.
- A history of ischemic heart disease.
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 and albuminTerlipressin dose: 2mg/24h, it will be modified depending on: Arterial pressure increase < 10 mmHg and the creatinine values decrease <25%, it will be increased every 8 hours until reaching an increase of at least 10mmHg arterial pressure or a creatinine decrease of the 25%. Albumin: Initial dose (first day) of 1g/Kg (up to a maximum of 100g) and the following days from 20 to 40 g/day. | Drug | terlipressin |
Primary outcome
Changes in arterial pressure and creatinine
Time frame: 4 months
3 secondary outcomes
Changes in plasmatic renin activity and aldosterone and noradrenaline concentration.
Time frame: 4 months
Treatment-related adverse events
Time frame: 4 months
Hepatorenal Syndrome reversion due to hemodynamic changes.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
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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.
German Soriano Pastor, MD principal investigator
gsoriano@santpau.cat
Juan Cordoba, MD principal investigator
jcordoba@vhebron.net
Isabel Cirera Lorenzo, MD principal investigator
ICirera@parcdesalutmar.cat
6 sites 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 and albumin in people with Cirrhosis and Hepatorenal Syndrome Type I, run by Pere Gines at 6 sites 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 5 inclusion and 10 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Changes in arterial pressure and creatinine (time frame: 4 months). 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 18 Aug 2016.