HepatitisPhase 3NCT00224705
The MARS® Albumin Dialysis System in Patients With Fulminant and Subfulminant Hepatic Failure
A Phase 3 study testing Molecular Adsorbent Recirculating System (MARS®) in people with Hepatitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to improve the survival rate of those patients with acute fulminant hepatitis through treatment with the MARS® extra-corporal liver-purification system by: 1. Reducing the number of patients who die before a graft is available 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis
- What is being tested?
- Molecular Adsorbent Recirculating System (MARS®)
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2004to Jan 2009
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with severe or sub-severe hepatitis, with an indication or a contraindication to liver transplantation
Who cannot join
- Sepsis severe not controlled
- Haemorrhage activates not controlled
- Clinical Obviousness of disseminated intravascular coagulation
- Severe Pathology cardiopulmonary (NYHA > or = 2)
- Pregnancy, breast feeding
- Average blood Pressure < 40 mmHg more than 10 minutes in spite of a support by the inotrope
Show all 13Show fewer
- Nonhepatic coma of origin
- Cholestases extra-hepatitic
- Antecedents of heavy surgery in the 4 previous weeks or surgical problems unsolved
- Absolute counter-indication with hepatic transplantation (extra Neoplasia hepatic evolutionary, irreversible cerebral Attack, irreversible multi-visceral Failure, visceral tares contra-indicating the transplantation)
- Positive serology HIV
- Hepatic Demonstrations of the malignant hemopathies
- Participation in another therapeutic test in the 4 previous weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of the Albumin Dialysis MARS® Therapy in Patients With Fulminant and Subfulminant Hepatic Failure
The purpose of this study is to improve the survival rate of those patients with acute fulminant hepatitis through treatment with the MARS® extra-corporal liver-purification system by:
- Reducing the number of patients who die before a graft is available
- Increasing the chances of survival without a liver transplant
- Reducing the pre- and post-operative mortality in transplant patients
Read the detailed description
Patients with fulminant or subfulminant hepatitis with either an indication or a relative contraindication to a liver transplantation, are randomized to two groups:
- A group treated with the conventional medical intensive treatment (including the hemodialysis techniques, continuous veno-venous hemofiltration or hemodiafiltration, if necessary) and the gold standard surgical treatment (liver transplantation) compared to
- A group receiving, in addition to the conventional medical intensive treatment, albumin dialysis using the MARS device and the gold standard surgical treatment (liver transplantation).
- Conditions
- Hepatitis
- Being tested
- Molecular Adsorbent Recirculating System (MARS®)
- Keywords
- Albumin dialysis, MARS system, Extracorporeal artificial liver support, Fulminant hepatitis, Subfulminant hepatitis, Acute liver failure
- Medical subject headings
- Hepatitis, Massive Hepatic Necrosis, Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular Adsorbent Recirculating System (MARS®)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival at six months
Measured: 6 months
Secondary outcomes (10)
Patient survival at six months without neurological sequelae
Measured: 6 months
Patient survival at 1 year
Measured: during one year
Graft survival at six months and 1 year
Measured: at 6 months and at one year
Number of patients who improve their liver function and no longer need a transplant in each stage of the trial
Measured: during one year
Hospital mortality before the transplant
Measured: during one year
Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale)
Measured: during one year
Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function
Measured: during one year
Evaluation of the safety parameters of the MARS® system (thromboembolism, risk of haemorrhage and infections)
Measured: during one year
Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant
Measured: during one year
duration of hospitalisation
Measured: during one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HepatitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Faouzi SALIBA, Pr, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224705
- Sponsor's protocol ID
- P030423
- Status last verified
- Jul 2007
- First submitted
- 19 Sep 2005
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Novelli G, Rossi M, Pretagostini R, Novelli L, Poli L, Ferretti G, Iappelli M, Berloco P, Cortesini R. A 3-year experience with Molecular Adsorbent Recirculating System (MARS): our results on 63 patients with hepatic failure and color Doppler US evaluation of cerebral perfusion. Liver Int. 2003;23 Suppl 3:10-5. doi: 10.1034/j.1478-3231.23.s.3.4.x.
PubMed 12950955Saliba F, Camus C, Durand F, Mathurin P, Letierce A, Delafosse B, Barange K, Perrigault PF, Belnard M, Ichai P, Samuel D. Albumin dialysis with a noncell artificial liver support device in patients with acute liver failure: a randomized, controlled trial. Ann Intern Med. 2013 Oct 15;159(8):522-31. doi: 10.7326/0003-4819-159-8-201310150-00005.
PubMed 24126646
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Albumin Dialysis MARS® Therapy in Patients With Fulminant and Subfulminant Hepatic Failure
- ClinicalTrials.gov ID
- NCT00224705
- Acronym / sponsor ID
- P030423
- Conditions
- Hepatitis
- Keywords
- Albumin dialysis, MARS system, Extracorporeal artificial liver support, Fulminant hepatitis, Subfulminant hepatitis, Acute liver failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 23 Sep 2005 (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 purpose of this study is to improve the survival rate of those patients with acute fulminant hepatitis through treatment with the MARS® extra-corporal liver-purification system by:
- Reducing the number of patients who die before a graft is available
- Increasing the chances of survival without a liver transplant
- Reducing the pre- and post-operative mortality in transplant patients
Detailed description
Patients with fulminant or subfulminant hepatitis with either an indication or a relative contraindication to a liver transplantation, are randomized to two groups:
- A group treated with the conventional medical intensive treatment (including the hemodialysis techniques, continuous veno-venous hemofiltration or hemodiafiltration, if necessary) and the gold standard surgical treatment (liver transplantation) compared to
- A group receiving, in addition to the conventional medical intensive treatment, albumin dialysis using the MARS device and the gold standard surgical treatment (liver transplantation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severe or sub-severe hepatitis, with an indication or a contraindication to liver transplantation
Key exclusion criteria (13 listed)
- Sepsis severe not controlled
- Haemorrhage activates not controlled
- Clinical Obviousness of disseminated intravascular coagulation
- Severe Pathology cardiopulmonary (NYHA > or = 2)
- Pregnancy, breast feeding
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 |
|---|---|---|
| Molecular Adsorbent Recirculating System (MARS®) | Device | – |
Primary outcome
Patient survival at six months
Time frame: 6 months
10 secondary outcomes
Patient survival at six months without neurological sequelae
Time frame: 6 months
Patient survival at 1 year
Time frame: during one year
Graft survival at six months and 1 year
Time frame: at 6 months and at one year
Number of patients who improve their liver function and no longer need a transplant in each stage of the trial
Time frame: during one year
Hospital mortality before the transplant
Time frame: during one year
Evaluation, at different stages, of the progression of the neurological condition (clinical and electroencephalographic stages, Glasgow scale)
Time frame: during one year
Evaluation at different stages, of the progression of biological parameters, which reflect liver and kidney function
Time frame: during one year
Evaluation of the safety parameters of the MARS® system (thromboembolism, risk of haemorrhage and infections)
Time frame: during one year
Economic elements: duration of stay in the Intensive Care Unit (ICU) up to the transplant and after the transplant
Time frame: during one year
duration of hospitalisation
Time frame: during one year
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 17 Feb 2011.
- Background: PubMed 12950955Novelli G, Rossi M, Pretagostini R, Novelli L, Poli L, Ferretti G, Iappelli M, Berloco P, Cortesini R. A 3-year experience with Molecular Adsorbent Recirculating System (MARS): our results on 63 patients with hepatic failure and color Doppler US evaluation of cerebral perfusion. Liver Int. 2003;23 Suppl 3:10-5. doi: 10.1034/j.1478-3231.23.s.3.4.x.
- Derived from this study: PubMed 24126646Saliba F, Camus C, Durand F, Mathurin P, Letierce A, Delafosse B, Barange K, Perrigault PF, Belnard M, Ichai P, Samuel D. Albumin dialysis with a noncell artificial liver support device in patients with acute liver failure: a randomized, controlled trial. Ann Intern Med. 2013 Oct 15;159(8):522-31. doi: 10.7326/0003-4819-159-8-201310150-00005.
Related trials for Hepatitis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
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.
Faouzi SALIBA, Pr, MD, PhD 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 3 study testing Molecular Adsorbent Recirculating System (MARS®) in people with Hepatitis, 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 1 inclusion and 13 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 17 Feb 2011. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Patient survival at six months (time frame: 6 months). 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 NCT00224705, which also lists 2 linked publications.
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 17 Feb 2011.