Protective Immune Mechanisms in Alcoholic Hepatitis | NCT01918462

Studies
Protective Immune Mechanisms in Alcoholic Hepatitis

NCT01918462

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Apr 29, 2021Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Alcoholic Hepatitis

Interventions

Not provided

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

ID	Type	Description	Link
AUH	Other Identifier	Aarhus University hospital

Status Module

Record Verification Date

Oct 2018

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

Apr 2013Actual

Primary Completion Date

Apr 20, 2018Actual

Completion Date

Apr 20, 2018Actual

First Submitted Date

Jun 25, 2013

First Submission Date that Met QC Criteria

Aug 5, 2013

First Posted Date

Aug 7, 2013Estimated

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

Apr 28, 2021

Last Update Posted Date

Apr 29, 2021Actual

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 production, effects and interactions of the hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis.

Detailed Description

The investigators will study hepatic biopsies from patients with alcoholic hepatitis. In these biopsies, the investigators will assess the production of IL-22 and which cells produce the cytokine. The investigators will study the expression of the IL-22 receptor and also the production of the IL-22 binding protein, which can inhibit the actions of the cytokine.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alcoholic hepatitis		Patients with alcoholic hepatic; cases.
Healthy controls		Persons undergoing hepatic resection; controls.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of IL-22-producing cells	This will be detected in hepatic biopsies taken at inclusion to the study.	at day 1 ( the day of diagnosis/arrival to the department)

Secondary Outcomes

Measure	Description	Time Frame
IL-22 binding protein	This will be detected in hepatic biopsies taken at inclusion to the study.	at day 1 ( the day of diagnosis/arrival to the department)
IL-22 receptor	This will be detected in hepatic biopsies taken at inclusion to the study.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of alcoholic hepatitis:
relevant history of alcohol consumption (>40g/day for a minimum of 6 months with cessation of consumption no earlier than 3 months prior to admission)
bilirubin > 80 mol/l
neutrophil granulocytes > 10x10^9/L
exclusion of other liver pathology including biliary disease
histological verification on liver biopsy
Written, informed consent

Exclusion Criteria:

Other chronic inflammatory or autoimmune diseases
Severe, acute bacterial infection (peritonitis, sepsis, pneumonia, urinary tract infection etc.)
Cancer
Prednisolon or pentoxifylline treatment within the past 8 weeks
Pregnancy

Accepts Healthy Volunteers

Yes

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

Patients admitted to the Department of hepatology and gastroenterology V, Aarhus University hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sidsel Støy, Phd student	Department of hepatology and gastroenterology, Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hepatology and gastroenterology V, Aarhus university hospital		Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006519	Hepatitis, Alcoholic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided