NCT02075918

Brief Summary

Purpose: To improve the diagnosis and assessment of severity of acute alcoholic hepatitis Participants: Patients admitted to one of ten centers with acute alcoholic hepatitis Procedures (methods): Consecutive patients admitted with acute alcoholic hepatitis will be enrolled in an NIH U01 study of acute alcoholic hepatitis where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity of disease and survival.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
376

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

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

February 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

5 years

First QC Date

February 27, 2014

Last Update Submit

June 5, 2019

Conditions

Alcoholic HepatitisControl Patients

Outcome Measures

Primary Outcomes (1)

  • Diagnosis and Severity of Alcoholic Hepatitis

    Utilizing liver tissue, blood samples, and stool and urine samples, InTeam will aim to discover and validate factors associated with the diagnosis and severity of Alcoholic hepatitis.

    3 months after end of Study

Secondary Outcomes (2)

  • Major Liver Complications

    3 months after end of study

  • Death/Transplantation

    3 months after end of study

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an episode of alcoholic hepatitis fulfilling the inclusion criteria will be eligible to participate in the study. Those patients who meet one or more exclusion criteria will not be included. Control patients

You may qualify if:

  • Patients 18 ≥ and ≤ 70 years of age.
  • Active alcohol abuse within the past 3 months.
  • Has an Aspartate Aminotransferase (AST) \> Alanine Aminotransferase (ALT).
  • Elevated Total Bilirubin level \> 3.0.
  • Absence of autoimmune liver disease (ANA\>1/320).
  • Absence of hepatitis B infection.
  • A liver biopsy, and/or a clinical picture consistent with alcoholic hepatitis.
  • The "Start Date" (is the date of the liver biopsy or ≤ to 1 week \[72 hours is preferred\] from the time of admission).

You may not qualify if:

  • Hepatocellular carcinoma.
  • Complete portal vein thrombosis.
  • Advanced or terminal extrahepatic diseases.
  • Lack of consent to participate in the study.
  • Pregnancy.
  • Received more than 3 days of treatment with (prednisolone or pentoxifyllin) prior to start date.
  • Control patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (1)

  • Lang S, Duan Y, Liu J, Torralba MG, Kuelbs C, Ventura-Cots M, Abraldes JG, Bosques-Padilla F, Verna EC, Brown RS Jr, Vargas V, Altamirano J, Caballeria J, Shawcross D, Lucey MR, Louvet A, Mathurin P, Garcia-Tsao G, Ho SB, Tu XM, Bataller R, Starkel P, Fouts DE, Schnabl B. Intestinal Fungal Dysbiosis and Systemic Immune Response to Fungi in Patients With Alcoholic Hepatitis. Hepatology. 2020 Feb;71(2):522-538. doi: 10.1002/hep.30832. Epub 2019 Aug 20.

    PMID: 31228214DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, Whole Blood DNA, PBMCs, Urine, Stool, Liver Biopsy

MeSH Terms

Conditions

Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Ramon Bataller, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 3, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2019

Study Completion

May 31, 2019

Last Updated

June 10, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)