Hepatic EncephalopathyPhase 4BETANCT02401490
Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy
A Phase 4 study testing Human albumin in people with Hepatic Encephalopathy and Cirrhosis, run by Hospital Universitari Vall d'Hebron Research Institute at 7 sites in Spain.
Trial summary
To assess whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatic Encephalopathy, Cirrhosis
- What is being tested?
- Human albumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 7 sitesSpain
- Study dates
- Apr 2015to Mar 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years.
- Liver cirrhosis defined by previous clinical data or liver biopsy.
- Presence of an episode of acute hepatic encephalopathy of grade> 2.
- Sign the informed consent
Who cannot join
- Pregnant or breast-feeding.
- Terminal illness.
- Presence of Acute-on-chronic liver failure.
- Needing for intensive support measures.
- Active gastrointestinal bleeding.
- neurological or psychiatric comorbidity that hinders the assessment of hepatic encephalopathy.
Show all 9Show fewer
- Clinical situations in which it is contraindicated to administer intravenous albumin.
- MELD score less than 15 or greater than 25 at the time of inclusion
- Any medical condition previous to patient inclusion in the study involving administration of albumin during a previous 7 day period.
Trial locations and contacts
7 sites in 1 country.
Joan Genescà Ferrer contact
7 sites in 1 country
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona
Helena Masnou, MD PhD
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Joan Genescà, MD PhD
Meritxell Ventura, MD
- Recruiting
Hospital Clínic de Barcelona
Barcelona
Elsa Solà, MD PhD
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
German Soriano, MD PhD
- Recruiting
Hospital del Mar
Barcelona
Nuria Cañete, MD
- Recruiting
Corporació Sanitària Parc Taulí
Sabadell, Barcelona
Jordi Sánchez, MD
- Recruiting
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona
Marta Martín, MD PhD
About this study
To assess whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation).
Read the detailed description
To evaluate whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 30, 90 and 180 days.
- to evaluate the effects of albumin on hepatic encephalopathy recurrence during the study period.
- To analyze whether albumin administration reduces hospitalization requirement.
- To study the effects of albumin on circulatory dysfunction index (mean arterial pressure, renal function, plasma vasopressor hormones).
- Conditions
- Hepatic Encephalopathy, Cirrhosis
- Being tested
- Human albumin, Placebo
- Medical subject headings
- Hepatic Encephalopathy, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human albuminDrug
1.5gr/Kg/day at least in the 24-48 hours after the hospitalization and 1.0 gr/Kg/day at 72 hours after the first dose.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Human albumin | Active comparator | human albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose. Receives: Drug: Human albumin |
| placebo | Placebo comparator | saline serum 0.9% Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation).
Measured: 90 days
Secondary outcomes (1)
Survival at 180 days.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- German Soriano, Principal investigator, Hospital de la Santa creu i Sant Pau - BarcelonaJordi Sanchez, Principal investigator, Corporació Sanitària Parc Taulí, SabadellHelena Masnou, Principal investigator, Hospital Universitari Germans Trias i Pujol, BadalonaNúria Cañete, Principal investigator, Hospital del MarMarta Martín, Principal investigator, Hospital de Sant Joan Despí Moisès Broggi, Sant Joan DespíElsa Solà, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401490
- Sponsor's protocol ID
- BETA
- Other IDs
- 2014-004809-33, 2014
- Acronym
- BETA
- Status last verified
- Dec 2017
- First submitted
- 24 Mar 2015
- Last updated
- 28 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT02401490
- Acronym / sponsor ID
- BETA / BETA
- Conditions
- Hepatic Encephalopathy, Cirrhosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Apr 2015
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 27 Mar 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.
To assess whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation).
Detailed description
To evaluate whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 30, 90 and 180 days.
- to evaluate the effects of albumin on hepatic encephalopathy recurrence during the study period.
- To analyze whether albumin administration reduces hospitalization requirement.
- To study the effects of albumin on circulatory dysfunction index (mean arterial pressure, renal function, plasma vasopressor hormones).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human albumin | Active comparator | Drug: Human albuminhuman albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose. |
| placebo | Placebo comparator | Drug: Placebosaline serum 0.9% |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 85 years.
- Liver cirrhosis defined by previous clinical data or liver biopsy.
- Presence of an episode of acute hepatic encephalopathy of grade> 2.
- Sign the informed consent
Key exclusion criteria (9 listed)
- Pregnant or breast-feeding.
- Terminal illness.
- Presence of Acute-on-chronic liver failure.
- Needing for intensive support measures.
- Active gastrointestinal bleeding.
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 |
|---|---|---|
| Human albumin1.5gr/Kg/day at least in the 24-48 hours after the hospitalization and 1.0 gr/Kg/day at 72 hours after the first dose. | Drug | Human albumin |
| Placebo | Drug | placebo |
Primary outcome
Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation).
Time frame: 90 days
1 secondary outcome
Survival at 180 days.
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
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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.
Joan Genescà Ferrer contact
German Soriano principal investigator
Hospital de la Santa creu i Sant Pau - Barcelona
Jordi Sanchez principal investigator
Corporació Sanitària Parc Taulí, Sabadell
Helena Masnou principal investigator
Hospital Universitari Germans Trias i Pujol, Badalona
7 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 Human albumin in people with Hepatic Encephalopathy and Cirrhosis, run by Hospital Universitari Vall d'Hebron Research Institute at 7 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 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: status not confirmed, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 Joan Genescà Ferrer (jgenesca@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation). (time frame: 90 days). 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 28 Dec 2017.