CirrhosisPhase 1/2DACARNCT00764049
Single Pass Albumin Dialysis in Patients With Cirrhosis
A Phase 1/2 study testing Single pass albumin dialysis in people with Cirrhosis and Acute on Chronic Hepatic Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Acute on Chronic Hepatic Failure, Hepatorenal Syndrome
- What is being tested?
- Single pass albumin dialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Jul 2012
- Phase
- Phase 1/2
- 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
- Minimum age of 18 years
- Written consent after information of the patient or, in case of inability, by a parent or a close if he is present.
- Patient having a cirrhosis researched by previous exams (liver biopsy) or, in the absence of previous diagnosis, diagnosed in view of the results of clinical, biological and morphological data, whatever the origin of the cirrhosis (virus of hepatitis B, virus of hepatitis C, extreme consumption of alcohol or other reasons)
Who cannot join
- Participation to an other study in the 4 weeks before
- Active digestive bleeding, unchecked by the pharmacological treatments and the endoscopic techniques.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Pilot Study Assessing Safety and Efficacy of Single Pass Albumin Dialysis in Patients With Acute on Chronic Liver Failure
The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.
Read the detailed description
Albumin dialysis has beneficial effects in patients with acute on chronic liver failure. However, current devices are complex and costly. The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.
- Being tested
- Single pass albumin dialysis
- Keywords
- Albumin dialysis, Artificial liver support, Acute on chronic liver failure
- Medical subject headings
- Fibrosis, Hepatorenal Syndrome, Brain Diseases, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single pass albumin dialysisDevice
6 hours sessions of albumin dialysis.
| Study group | Role | What they receive |
|---|---|---|
| 1: Single pass albumin dialysis | Experimental | Patients entered in the pilot study. Receives: Device: Single pass albumin dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on clinical and biochemical variables
Measured: 3 months follow-up
Secondary outcomes (1)
Safety
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startJun 2009
- Primary completionJan 2012
- Study completionJul 2012
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 Assistance Publique - Hôpitaux de ParisThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire français de Fractionnement et de Biotechnologies, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- François Durand, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764049
- Sponsor's protocol ID
- P050902
- Acronym
- DACAR
- Status last verified
- Feb 2015
- First submitted
- 30 Sep 2008
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study Assessing Safety and Efficacy of Single Pass Albumin Dialysis in Patients With Acute on Chronic Liver Failure
- ClinicalTrials.gov ID
- NCT00764049
- Acronym / sponsor ID
- DACAR / P050902
- Keywords
- Albumin dialysis, Artificial liver support, Acute on chronic liver failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Laboratoire français de Fractionnement et de Biotechnologies, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jun 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Oct 2008 (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.
The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.
Detailed description
Albumin dialysis has beneficial effects in patients with acute on chronic liver failure. However, current devices are complex and costly. The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1: Single pass albumin dialysis | Experimental | Device: Single pass albumin dialysisPatients entered in the pilot study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Minimum age of 18 years
- Written consent after information of the patient or, in case of inability, by a parent or a close if he is present.
- Patient having a cirrhosis researched by previous exams (liver biopsy) or, in the absence of previous diagnosis, diagnosed in view of the results of clinical, biological and morphological data, whatever the origin of the cirrhosis (virus of hepatitis B, virus of hepatitis C, extreme consumption of alcohol or other reasons)
Key exclusion criteria (2 listed)
- Participation to an other study in the 4 weeks before
- Active digestive bleeding, unchecked by the pharmacological treatments and the endoscopic techniques.
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 |
|---|---|---|
| Single pass albumin dialysis6 hours sessions of albumin dialysis. | Device | 1: Single pass albumin dialysis |
Primary outcome
Effects on clinical and biochemical variables
Time frame: 3 months follow-up
1 secondary outcome
Safety
Time frame: 3 months
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 25 Feb 2015.
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
François Durand, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Single pass albumin dialysis in people with Cirrhosis and Acute on Chronic Hepatic Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 2 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 25 Feb 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 France. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Effects on clinical and biochemical variables (time frame: 3 months follow-up). 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 25 Feb 2015.