This study is currently not recruiting participants.

A Multicenter Randomized Double-Blind Placebo-controlled Dosing Safety and Efficacy Study of IMM 124-E (Hyperimmune Bovine Colostrum) for Patients with Severe Alcoholic Hepatitis

Investigating the Safety and Effectiveness of an Investigational Medication for Severe Alcoholic Hepatitis

Not Recruiting
21 years - 100 years
All
Phase N/A

Brief description of study.

The purpose of this study is to test the safety, tolerability, and effectiveness of Imm 124-E (Bovine Colostrum Drug Substance or BCDS) when used to treat severe alcoholic hepatitis.

Detailed description of study

The purpose of this study is to test the safety, tolerability, and effectiveness of Imm 124-E (Bovine Colostrum Drug Substance or BCDS) when used to treat severe alcoholic hepatitis.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: hepatitis
  • Age: 21 years - 100 years
  • Gender: All

This study investigates the safety and effectiveness of an investigational medication for treating severe alcoholic hepatitis. Severe alcoholic hepatitis is a serious condition caused by excessive drinking, leading to inflammation and damage to the liver. The investigational medication being studied is derived from bovine colostrum, which is the first form of milk produced by cows after giving birth.

Participants in this study will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study aims to assess how well patients tolerate the treatment and its impact on their condition.

  • Who can participate: Eligibility criteria include adults aged 18 and older diagnosed with severe alcoholic hepatitis. Key factors include stable medical condition and no participation in other clinical trials.
  • Study details: Participants will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
Updated on 19 Feb 2024. Study ID: 1408909595

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