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Guselkumab 100mg for Alcoholic Liver Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alcoholic Liver DiseaseGuselkumab 100mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety of a drug not approved for alcoholic liver disease in up to 24 patients. The goal is to also establish if the drug is effective in treating the disease by measuring biomarkers for liver inflammation and fibrosis.

Eligible Conditions
  • Alcoholic Liver Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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INT-787
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Active Comparator: Lactobacillus Rhamnosus GG
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Arm1: DUR-928 treatment for moderate alcoholic hepatitis

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 48 Weeks

48 Weeks
Assess the safety and tolerability of Guselkumab

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
INT-787
2
Active Comparator: Lactobacillus Rhamnosus GG
2
Arm1: DUR-928 treatment for moderate alcoholic hepatitis

Trial Design

3 Treatment Groups

Guselkumab 70 mg
1 of 3
Guselkumab 100mg
1 of 3
Guselkumab 30mg
1 of 3

Experimental Treatment

24 Total Participants · 3 Treatment Groups

Primary Treatment: Guselkumab 100mg · No Placebo Group · Phase 1

Guselkumab 70 mg
Drug
Experimental Group · 1 Intervention: Guselkumab 70mg · Intervention Types: Drug
Guselkumab 100mg
Drug
Experimental Group · 1 Intervention: Guselkumab 100mg · Intervention Types: Drug
Guselkumab 30mg
Drug
Experimental Group · 1 Intervention: Guselkumab 30mg · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48 weeks

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,028 Previous Clinical Trials
1,805,997 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have made at least one unsuccessful attempt to cut down or control alcohol use.
You continue to drink alcohol despite having persistent or recurrent social or interpersonal problem caused or exacerbated by the effects of the alcohol.
You are able to provide written informed consent.
Alcohol is often taken in larger amounts and/or over a longer period than the patient intended.
A great deal of time is spent in activities necessary to obtain alcohol, use alcohol, or recover from effects.
You have a pattern of recurrent alcohol use that interferes with your major role obligations at work, school, or home.
You have given up or reduced important social, occupational or recreational activities because of alcohol use.
You have used alcohol in situations in which it is physically hazardous.
References

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