Single Pass Albumin Dialysis in Patients With Cirrhosis | NCT00764049

Studies
Single Pass Albumin Dialysis in Patients With Cirrhosis

NCT00764049

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Feb 25, 2015Estimated

Enrollment

11Actual

Phase

Phase 1Phase 2

Conditions

Cirrhosis
Acute on Chronic Hepatic Failure
Hepatorenal Syndrome
Encephalopathy

Interventions

Single pass albumin dialysis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Sep 30, 2008

First Submission Date that Met QC Criteria

Sep 30, 2008

First Posted Date

Oct 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2015

Last Update Posted Date

Feb 25, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Name	Class
Laboratoire français de Fractionnement et de Biotechnologies	INDUSTRY
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1: Single pass albumin dialysis	Experimental	Patients entered in the pilot study.	Device: Single pass albumin dialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Single pass albumin dialysis	Device	6 hours sessions of albumin dialysis.	1: Single pass albumin dialysis

Measure	Description	Time Frame
Effects on clinical and biochemical variables		3 months follow-up

Measure	Description	Time Frame
Safety		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François Durand, Pr	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Beaujon		Clichy		92110	France

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D006530	Hepatorenal Syndrome
D001927	Brain Diseases
D065290	Acute-On-Chronic Liver Failure

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided