NCT00764049

Brief Summary

The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2009

Typical duration for phase_1

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

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 25, 2015

Status Verified

February 1, 2015

Enrollment Period

2.6 years

First QC Date

September 30, 2008

Last Update Submit

February 24, 2015

Conditions

CirrhosisAcute on Chronic Hepatic FailureHepatorenal SyndromeEncephalopathy

Keywords

Albumin dialysisArtificial liver supportAcute on chronic liver failure

Outcome Measures

Primary Outcomes (1)

  • Effects on clinical and biochemical variables

    3 months follow-up

Secondary Outcomes (1)

  • Safety

    3 months

Study Arms (1)

1: Single pass albumin dialysis

EXPERIMENTAL

Patients entered in the pilot study.

Device: Single pass albumin dialysis

Interventions

Single pass albumin dialysisDEVICE

6 hours sessions of albumin dialysis.

1: Single pass albumin dialysis

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • Participation to an other study in the 4 weeks before
  • Active digestive bleeding, unchecked by the pharmacological treatments and the endoscopic techniques.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Beaujon

Clichy, 92110, France

Location

MeSH Terms

Conditions

FibrosisHepatorenal SyndromeBrain DiseasesAcute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCentral Nervous System DiseasesNervous System DiseasesLiver Failure, AcuteLiver FailureHepatic Insufficiency

Study Officials

  • François Durand, Pr

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 1, 2008

Study Start

June 1, 2009

Primary Completion

January 1, 2012

Study Completion

July 1, 2012

Last Updated

February 25, 2015

Record last verified: 2015-02

Locations

FR(1)