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Guselkumab for Alcoholic Liver Disease
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not pregnant, breastfeeding, or have a positive pregnancy test.I have an autoimmune liver disease.I do not have any major illnesses that would stop me from completing the study.I have a blood vessel disorder in my liver.I have cirrhosis confirmed by imaging or lab tests.I have never used guselkumab or similar medications, nor am I allergic to them.I have tested positive for hepatitis B surface antigen.I have had an organ transplant, but not a cornea transplant.I agree to use birth control during the study.I am using or willing to use birth control if I can have children.I have no active cancers except for treated skin cancer or any diagnosed in the last 5 years.I am 21 or older with a BMI between 20 and 45.I have signs of advanced liver disease like enlarged spleen or fluid in the abdomen.I need medication to help my heart pump more effectively.I am 21 or older with a BMI between 20 and 45.I have signs of high blood pressure in the liver, like fluid in the belly or swollen veins in my stomach or esophagus.I have had breast, prostate, or any cancer in the last 5 years.I am currently taking medications like chloroquine or paclitaxel.I do not have any other liver diseases.I have liver problems caused by medication.I have acute hepatitis A.I have active tuberculosis.I have had skin cancer in the past year.My liver is damaged.I have hepatitis C with severe liver damage or my condition is stable.
- Group 1: Guselkumab 30mg
- Group 2: Guselkumab 70 mg
- Group 3: Guselkumab 100mg
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has a similar trial ever been conducted before?
"Since its initial evaluation in 2018, which was conducted by Janssen Research & Development, LLC and included 1,406 participants, Guselkumab 100mg has been subject to further exploration. Subsequently receiving approval for Phase 2 & 3 trials the drug is now being studied across 57 countries with 19 active evaluations taking place in 286 cities worldwide."
Has Guselkumab 100mg previously been assessed in any other clinical experiments?
"Currently, 19 trials of Guselkumab 100mg are active. 7 of these clinical studies have advanced to the third phase. While much research is being done in Milan and Kansas, there are a total 2732 locations conducting experiments with this drug."
Is Guselkumab 100mg considered to be a safe therapeutic option?
"Guselkumab 100mg's safety profile is only partially known, so it was rated a 1 on our internal scale. This makes sense considering that this experimental drug remains in its initial assessment stage."
Is this experimentation actively accepting new participants?
"Affirmative. According to information obtained from clinicaltrials.gov, this medical study is actively seeking participants and has been recruiting since March 3rd 2021. The research team aims to enroll 24 patients at a single location."
What is the estimated sample size for this experimental research?
"Affirmative. According to the information on clinicaltrials.gov, this medical trial is in recruitment mode. Originally posted on March 3rd 2021 and last updated on May 3rd 2021, it requires 24 participants from one site only."
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