Inflammation, Immune Activation and Portal Hypertension i... | NCT00992888

Studies
Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis

NCT00992888

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Sep 15, 2011Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Alcoholic Hepatitis

Interventions

Prometheus Liver Dialysis system (Fresenius Medical Care)

Countries

Denmark

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

Sep 2011

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

Aug 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Oct 8, 2009

First Submission Date that Met QC Criteria

Oct 8, 2009

First Posted Date

Oct 9, 2009Estimated

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

Sep 14, 2011

Last Update Posted Date

Sep 15, 2011Estimated

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 purpose of this study is to investigate the role of endotoxins and the endotoxin mediated immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect of Liver assist (liver dialyses) intervention on these parameters in patients with severe alcoholic hepatitis.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
albumin liver dialysis	Experimental		Device: Prometheus Liver Dialysis system (Fresenius Medical Care)
Standard medial care without dialysis	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prometheus Liver Dialysis system (Fresenius Medical Care)	Device	6 hour dialysis for 3 consecutive days	albumin liver dialysis

Measure	Description	Time Frame
Serum endotoxin levels		one year

Measure	Description	Time Frame
Endotoxin activation pathway proteins		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with alcoholic hepatitis based on the following criteria

Alcohol intake for 6 consecutive months above 40g /day, at admission or 3 months earlier.
Serum bilirubin level above 80 mmol/l
exclusion of other types of liver disease.
Liver biopsy when diagnosis is unclear.

Exclusion Criteria:

Heart failure
Pregnancy
non fluent danish speakers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hendrik Vilstrup, Prof	Department of Medicine V, Aarhus University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine V, Aarhus University Hospital		Aarhus		8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25501547	Derived	Stoy S, Dige A, Sandahl TD, Laursen TL, Buus C, Hokland M, Vilstrup H. Cytotoxic T lymphocytes and natural killer cells display impaired cytotoxic functions and reduced activation in patients with alcoholic hepatitis. Am J Physiol Gastrointest Liver Physiol. 2015 Feb 15;308(4):G269-76. doi: 10.1152/ajpgi.00200.2014. Epub 2014 Dec 11.

ID	Term
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D008108	Liver Diseases, Alcoholic