Treatment for Hepatitis A

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Baylor St. Luke Medical Center, Houston, TX
Hepatitis A+3 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a probiotic can improve the diversity of the intestinal microbiome in people with severe alcoholic hepatitis.

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Eligible Conditions

  • Hepatitis A
  • Alcoholic Hepatitis (AH)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 5 primary outcomes and 20 secondary outcomes in patients with Hepatitis A. Measurement will happen over the course of At [Baseline] [4 weeks].

Month 9
To assess change in the Lille Model from baseline in the study population at 9 months.
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 9 months.
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 9 months.
At [Baseline] [12 month]
To assess change in the Lille Model from baseline in the study population and at 12 months.
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 12 months.
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 12 months.
At [Baseline] [12 months]
To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 12 months.
At [Baseline] [12 weeks]
To assess change in the Lille Model from baseline in the study population at 12 weeks.
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 12 weeks.
To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 12 weeks.
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 12 weeks.
At [Baseline] [12months]
To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 12 months.
At [Baseline] [4 weeks]
To assess change in the Lille Model from baseline in the study population at 4 weeks.
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 4 weeks.
To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 4 weeks.
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 4 weeks.
To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 4 weeks.
At [Baseline] [6 month]
To assess change in the Lille Model from baseline in the study population at 6 months.
To assess change in the Maddrey's Discriminant Function (Maddrey DF) from baseline in the study population at 6 months.
To assess change in the prognostic scores of Model for Glasgow Alcoholic Hepatitis Score (GAHS) from baseline in the study population at 6 months.
At [Baseline] [6 months]
To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 6 months.
To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 6 months.
At [Baseline] [9 months]
To assess change in the prognostic scores of Model for End Stage Liver Disease (MELD) from baseline in the study population at 9 months.
To assess the change in gut microbiome population associated with severe alcoholic hepatitis patients from baseline in study population at 9 months.
[Day1 to 12 month]
To Assess survival in patients with severe alcoholic hepatitis receiving PRIM-DJ2727 capsules in comparison to standard of care.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Intervention Arm
1 of 2
Placebo Arm
1 of 2
Active Control
Non-Treatment Group

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Intervention Arm
Biological
Subjects will receive Standard of Care (SOC), based on AASLD/EASL guidelines and one dose of PRIM-DJ2727 (30 grams of stool/dose ~ 3 capsules) every day for a week followed by once weekly for 3 weeks, amounting to total 10 doses. PRIM-DJ2727 (microbiota suspension) is an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors. It will be provided by University of Texas School of Public Health.
Placebo Arm
Other
Subjects will receive Standard of Care (SOC), based on AASLD/EASL guidelines and one dose of Placebo every day for a week followed by once weekly for 3 weeks, amounting to total 10 doses. Placebo will be identical to the investigational product but will not contain active PRIM-DJ2727.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at [baseline] [12 month]
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at [baseline] [12 month] for reporting.

Closest Location

Baylor St. Luke Medical Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Hepatitis A or one of the other 3 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Any gender; male or female; aged 18- 75 years old.
Severe alcoholic hepatitis defined as 2.1 Onset of jaundice within prior 8 weeks. 2.2 Ongoing alcohol consumption of >40 g/day (3 drinks) in females or >60 g/day (4 drinks) in males for 6 months or more, with less than 60 days of abstinence before the onset of jaundice. 2.3 Aspartate aminotransferase >50, Aspartate aminotransferase/Alanine aminotransferase ratio > 1.5, BUT both values <400 IU/L.
2.4 Serum total bilirubin >3.0 mg/dl. 2.5 MELD score >15 and/or Maddrey DF score of ≥32.

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

There is not cost involved in participating in this trial, so insurance won't be necessary.

See if you qualify for this trial
Get access to this novel treatment for Hepatitis A by sharing your contact details with the study coordinator.