Trial Outcomes & Findings for Alcoholic Hepatitis Network Observational Study (NCT NCT03850899)

NCT ID: NCT03850899

Last Updated: 2025-02-14

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 1133 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2025-02-14

Participant Flow

Participant milestones

Measure	Cases Heavy drinkers with alcoholic hepatitis	Controls Heavy drinkers without significant liver disease	Donor Healthy non-drinkers
Overall Study STARTED	717	257	159
Overall Study COMPLETED	230	118	159
Overall Study NOT COMPLETED	487	139	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alcoholic Hepatitis Network Observational Study

Baseline characteristics by cohort

Measure	Cases n=717 Participants Heavy drinkers with alcoholic hepatitis	Controls n=257 Participants Heavy drinkers without significant liver disease	Donor n=159 Participants Healthy non-drinkers	Total n=1133 Participants Total of all reporting groups
Sex: Female, Male Female	294 Participants n=5 Participants	109 Participants n=7 Participants	99 Participants n=5 Participants	502 Participants n=4 Participants
Sex: Female, Male Male	423 Participants n=5 Participants	148 Participants n=7 Participants	60 Participants n=5 Participants	631 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	63 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants	86 Participants n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	694 Participants n=5 Participants	229 Participants n=7 Participants	156 Participants n=5 Participants	1079 Participants n=4 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants	28 Participants n=7 Participants	3 Participants n=5 Participants	54 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	638 Participants n=5 Participants	247 Participants n=7 Participants	140 Participants n=5 Participants	1025 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	0 Participants n=7 Participants	27 Participants n=5 Participants	31 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Black or African American	82 Participants n=5 Participants	64 Participants n=7 Participants	18 Participants n=5 Participants	164 Participants n=4 Participants
Race (NIH/OMB) White	601 Participants n=5 Participants	183 Participants n=7 Participants	101 Participants n=5 Participants	885 Participants n=4 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	31 Participants n=4 Participants
Region of Enrollment United States	717 participants n=5 Participants	257 participants n=7 Participants	159 participants n=5 Participants	1133 participants n=4 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Measure	Cases n=717 Participants Heavy drinkers with alcoholic hepatitis	Controls n=257 Participants Heavy drinkers without significant liver disease	Donor n=159 Participants Healthy non-drinkers
Number of Subjects With Clinical Data Collected	717 Participants	257 Participants	159 Participants

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Measure	Cases n=717 Participants Heavy drinkers with alcoholic hepatitis	Controls n=257 Participants Heavy drinkers without significant liver disease	Donor n=159 Participants Healthy non-drinkers
Number of Subjects With Bio-samples Collected	698 Participants	247 Participants	159 Participants

Adverse Events

Cases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 194 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Donor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samer Gawrieh

Indiana University School of Medicine

Phone: (317) 278-9326

Email: sgawrieh@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place