CirrhosisPhase 4NCT00968695
Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.
A Phase 4 study testing Albumin in people with Cirrhosis and Ascites, run by Instituto Grifols, S.A. at 6 sites in Spain.
Trial summary
Effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 6 sitesSpain
- Study dates
- Jul 2009to Apr 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years and less than 80 years.
- Diagnosis of liver cirrhosis by biopsy or by clinical, laboratory, or ultrasound.
- Daily requirement of diuretics at least 200mg of spironolactone or 100mg of spironolactone and 40 mg of furosemide
- Renal dysfunction defined by a plasma concentration of serum creatinine ≥ 1.2 mg / dl, blood urea nitrogen ≥ 25 mg / dl or a serum sodium concentration ≤ 130 mEq / L.
Who cannot join
- Refractory Ascites (paracentesis requirements over 1 month.
- Neoplastic disease including liver cancer if it exceeds the Milan criteria (one nodule> 5 cm or three nodules> 3 cm).
- History of transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt
- Gastrointestinal bleeding or bacterial infection documented in the past 15 days.
- Heart failure or structural heart disease.
- Organic renal insufficiency(proteinuria, hematuria and / or ultrasound data nephropathy).
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- Moderate or severe lung chronic disease.
- Transplant.
- Infection with human immunodeficiency virus.
- Active addiction to drugs.
- Mental state that prevents the patient understand the nature, extent and consequences of the study, except for hepatic encephalopathy.
- Pregnancy.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Clínic of Barcelona
Barcelona, 08036
Hospital Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28034
About this study
Official title: Clinical Trial on the Effects of Long Term Administration of 20% Albumin in the Cardiovascular and Renal Function, And Hepatic Hemodynamics in Advanced Patients With Cirrhosis and Ascites.
Effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.
Read the detailed description
Pharmacodynamic study of pathophysiological nature to assess the effects of prolonged administration of human albumin in the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.
- Being tested
- Albumin
- Medical subject headings
- Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminDrug
Also called Albutein 20%
The pattern of administration of 20% human albumin is 1.5g/kg every week to be infused in 6 hours with a minimum of 90g up and a maximum of 150g in patients weighing less than 60 kg and more than 100 kg, respectively. Treatment duration is 12 weeks, which are 13 administrations of albumin.
| Study group | Role | What they receive |
|---|---|---|
| Albumin | Experimental | The subjects will be receiving albumin 20% infusions Receives: Drug: Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses change from Baseline plasma renin concentration at Week 14
Plasma renin activity will be measured at Baseline and Week 14
Measured: 14 weeks
To asses change from Baseline plasma renin concentration at Week 20
Plasma renin activity will be measured at Baseline and Week 20
Measured: 20 weeks
To asses change from Baseline plasma concentration of noradrenaline at week 14
Plasma noradrenaline concentration will be measured at Baseline and Week 14
Measured: 14 weeks
To asses change from Baseline plasma concentration of noradrenaline at Week 20
Plasma noradrenaline concentration will be measured at Baseline and Week 20
Measured: 20 weeks
To assess change from Baseline glomerular filtration rate at Week 14
Glomerular filtration rate will be measured at Baseline and Week 14
Measured: 14 weeks
To assess change from Baseline glomerular filtration rate at Week 20
Glomerular filtration rate will be measured at Baseline and Week 20
Measured: 20 weeks
To assess change from Baseline cardiac output at Week 14
Cardiac output will be measured at Baseline and Week 14
Measured: 14 weeks
To assess change from Baseline cardiopulmonary pressures at Week 14
Cardiopulmonary pressures will be measured at Baseline and Week 14
Measured: 14 weeks
To assess change from Baseline free hepatic pressure at Week 14
Free hepatic pressure will be measured at Baseline and Week 14
Measured: 14 weeks
To assess change from Baseline wedged hepatic pressure at Week 14
Wedged hepatic pressure will be measured at Baseline and Week 14
Measured: 14 weeks
To assess change from Baseline echocardiography at Week 14
Echocardiography will be measured at Baseline and Week 14
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Sponsor
- Investigators
- Vicente Arroyo, MD, Principal investigator, Hospital Clínic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968695
- Sponsor's protocol ID
- IG0802
- Status last verified
- Jun 2019
- First submitted
- 28 Aug 2009
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.
PubMed 30905652
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Effects of Long Term Administration of 20% Albumin in the Cardiovascular and Renal Function, And Hepatic Hemodynamics in Advanced Patients With Cirrhosis and Ascites.
- ClinicalTrials.gov ID
- NCT00968695
- Acronym / sponsor ID
- IG0802
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- Jul 2009 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 Aug 2009 (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.
Effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.
Detailed description
Pharmacodynamic study of pathophysiological nature to assess the effects of prolonged administration of human albumin in the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Albumin | Experimental | Drug: AlbuminThe subjects will be receiving albumin 20% infusions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age above 18 years and less than 80 years.
- Diagnosis of liver cirrhosis by biopsy or by clinical, laboratory, or ultrasound.
- Daily requirement of diuretics at least 200mg of spironolactone or 100mg of spironolactone and 40 mg of furosemide
- Renal dysfunction defined by a plasma concentration of serum creatinine ≥ 1.2 mg / dl, blood urea nitrogen ≥ 25 mg / dl or a serum sodium concentration ≤ 130 mEq / L.
Key exclusion criteria (12 listed)
- Refractory Ascites (paracentesis requirements over 1 month.
- Neoplastic disease including liver cancer if it exceeds the Milan criteria (one nodule> 5 cm or three nodules> 3 cm).
- History of transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt
- Gastrointestinal bleeding or bacterial infection documented in the past 15 days.
- Heart failure or structural 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 |
|---|---|---|
| AlbuminAlso: Albutein 20%The pattern of administration of 20% human albumin is 1.5g/kg every week to be infused in 6 hours with a minimum of 90g up and a maximum of 150g in patients weighing less than 60 kg and more than 100 kg, respectively. Treatment duration is 12 weeks, which are 13 administrations of albumin. | Drug | Albumin |
Primary outcome
To asses change from Baseline plasma renin concentration at Week 14
Time frame: 14 weeks
Plasma renin activity will be measured at Baseline and Week 14
To asses change from Baseline plasma renin concentration at Week 20
Time frame: 20 weeks
Plasma renin activity will be measured at Baseline and Week 20
To asses change from Baseline plasma concentration of noradrenaline at week 14
Time frame: 14 weeks
Plasma noradrenaline concentration will be measured at Baseline and Week 14
To asses change from Baseline plasma concentration of noradrenaline at Week 20
Time frame: 20 weeks
Plasma noradrenaline concentration will be measured at Baseline and Week 20
To assess change from Baseline glomerular filtration rate at Week 14
Time frame: 14 weeks
Glomerular filtration rate will be measured at Baseline and Week 14
To assess change from Baseline glomerular filtration rate at Week 20
Time frame: 20 weeks
Glomerular filtration rate will be measured at Baseline and Week 20
To assess change from Baseline cardiac output at Week 14
Time frame: 14 weeks
Cardiac output will be measured at Baseline and Week 14
To assess change from Baseline cardiopulmonary pressures at Week 14
Time frame: 14 weeks
Cardiopulmonary pressures will be measured at Baseline and Week 14
To assess change from Baseline free hepatic pressure at Week 14
Time frame: 14 weeks
Free hepatic pressure will be measured at Baseline and Week 14
To assess change from Baseline wedged hepatic pressure at Week 14
Time frame: 14 weeks
Wedged hepatic pressure will be measured at Baseline and Week 14
To assess change from Baseline echocardiography at Week 14
Time frame: 14 weeks
Echocardiography will be measured at Baseline and Week 14
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 26 Jun 2019.
- Derived from this study: PubMed 30905652Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.
- Individual participant dataSharing planned: No
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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.
Vicente Arroyo, MD principal investigator
Hospital Clínic of Barcelona
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 Albumin in people with Cirrhosis and Ascites, run by Instituto Grifols, S.A. 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 4 inclusion and 12 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 26 Jun 2019. 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?
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 asses change from Baseline plasma renin concentration at Week 14 (time frame: 14 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00968695, which also lists 1 linked publication.
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 26 Jun 2019.