NCT00224705

Brief 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. 1.Reducing the number of patients who die before a graft is available
  2. 2.Increasing the chances of survival without a liver transplant
  3. 3.Reducing the pre- and post-operative mortality in transplant patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 17, 2011

Status Verified

July 1, 2007

Enrollment Period

4.4 years

First QC Date

September 19, 2005

Last Update Submit

February 16, 2011

Conditions

Hepatitis

Keywords

Albumin dialysisMARS systemExtracorporeal artificial liver supportFulminant hepatitisSubfulminant hepatitisAcute liver failure

Outcome Measures

Primary Outcomes (1)

  • Patient survival at six months

    6 months

Secondary Outcomes (10)

  • Patient survival at six months without neurological sequelae

    6 months

  • Patient survival at 1 year

    during one year

  • Graft survival at six months and 1 year

    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

    during one year

  • Hospital mortality before the transplant

    during one year

  • +5 more secondary outcomes

Interventions

Molecular Adsorbent Recirculating System (MARS®)DEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with severe or sub-severe hepatitis, with an indication or a contraindication to liver transplantation

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Paul Brousse

Villejuif, 94800, France

Location

Related Publications (2)

  • 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.

    PMID: 12950955BACKGROUND

  • Saliba 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.

    PMID: 24126646DERIVED

MeSH Terms

Conditions

HepatitisMassive Hepatic NecrosisLiver Failure, Acute

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesChemical and Drug Induced Liver InjuryLiver FailureHepatic Insufficiency

Study Officials

  • Faouzi SALIBA, Pr, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 23, 2005

Study Start

August 1, 2004

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 17, 2011

Record last verified: 2007-07

Locations

FR(1)