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Setanaxib for Primary Biliary Cholangitis (TRANSFORM Trial)
TRANSFORM Trial Summary
This trial is studying setanaxib to see if it can improve outcomes in people with primary biliary cholangitis who haven't responded well to other treatments.
TRANSFORM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TRANSFORM Trial Design
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Who is running the clinical trial?
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- My bilirubin levels are high, but my albumin levels are normal.I have had a liver transplant, am waiting for one, or have severe liver disease.I use birth control that contains only progestogen.I have never used setanaxib or been in a setanaxib study before.I have had serious liver problems, including bleeding, confusion due to liver disease, severe infection in my abdomen, fluid buildup needing treatment, or have been listed for a liver transplant.I have cirrhosis with complications, such as liver cancer.I have been on OCA, fenofibrate, or bezafibrate for 6+ months with a stable dose for over 3 months.I haven't needed antibiotics for an infection in the last 2 weeks.I do not have conditions like Paget's disease that affect my ALP levels.I haven't taken any prohibited medications in the last 3 months.My kidney function is reduced, with an eGFR below 60.I have had cancer within the last 5 years, but it may still be okay depending on the type.I am 18 years old or older.I stopped taking bezafibrate or fenofibrate more than 3 months ago.I have antibodies indicating primary biliary cholangitis (PBC).My fallopian tubes are surgically blocked.I agree to use a condom and ensure my partner uses birth control during and for 90 days after the trial.I am abstaining from sexual activity for the study's duration.I agree not to donate sperm/eggs for 90 days after my last treatment dose.My INR is above 1.2, but I am on blood thinners.I do not have other liver diseases like hepatitis C, unless cured for 6 months, active hepatitis B, NASH, alcoholic liver disease, autoimmune hepatitis, or others.I have had treatment for a non-spreading skin cancer.I am using a combined hormonal birth control method.I have been on a stable dose of UDCA for over 3 months or am intolerant to UDCA.I am a woman who can have children and have tested negative for pregnancy.I am using or will use effective birth control before and after the trial.My drug test was positive, but it's due to my prescribed medication.My cervical cancer in situ has been properly treated.I have a history of bone marrow disorders or severe anemia.My heart condition is not stable.I stopped taking OCA over 3 months ago due to intolerance.I have had surgery or a condition that could affect how my body absorbs medication.
- Group 1: Setanaxib 1200 mg/day
- Group 2: Setanaxib 1600 mg/day
- Group 3: Placebo
- 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
Are there any more patients that can be enrolled in this trial?
"That is correct. The online information hosted by clinicaltrials.gov affirms that this trial is still recruiting patients. 318 individuals are needed for the study which has 27 different sites; the trial was first posted on February 14th, 2022 and was updated most recently on October 25th of the same year."
Could you tell me how many hospitals in the U.S. are participating in this research project?
"This clinical trial is taking place at 27 different locations, some of which include University of Miami Leonard M. Miller School of Medicine in Miami, Wake Forest University Baptist Medical Center in Winston-Salem, and Centricity Research (LMC Manna Research) - London in London."
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