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Do you have Primary Biliary Cholangitis (PBC) that is not responding?
About PBC
PBC is an autoimmune disease (caused when your immune system attacks your body) that damages the bile ducts in the liver. Normally, bile travels through these ducts to the small intestine where it helps with digestion. When the ducts are damaged, bile builds up in the liver, causing inflammation and scarring. PBC worsens over time and can eventually lead to cirrhosis of the liver and possibly the need for a liver transplant.
A medication called ursodeoxycholic acid (UDCA) is approved to treat PBC but many people do not adequately respond to it. The PRONTO-PBC study drug may help people whose PBC has not responded to UDCA alone.
What is the PRONTO-PBC study?
The goal of the PRONTO-PBC study is to measure the effectiveness of the study drug at helping people with PBC who have not responded to standard therapy. The study lasts for about 20 weeks (5 months).
What is the study drug?
The study drug is based on two separate medications being formed into one new drug. The first of these, called UDCA, is the standard medication used to treat PBC. The second part of the study drug is called berberine which, by itself, is widely used as an over-the-counter medication and is known for its antibacterial and anti-inflammatory abilities. The study drug is designed to improve liver damage caused by PBC, and it may help people whose PBC has not responded to UDCA alone.
The study drug is investigational, which means it has not been approved by regulatory authorities like the US Food and Drug Administration (FDA) as a therapy for PBC.
Who can join the study?
You may be able to participate in the study if you meet the following requirements*:
- You are between 18 and 75 years old
- You have a confirmed diagnosis of PBC
- On stable dose of ursodeoxycholic acid (also known as UDCA, ursodiol, urso) for at least 6 months
- You are willing to stop taking UDCA while participating in the study
- Interested in participating in a study evaluating the effectiveness of HTD1801 for PBC treatment
* Additional criteria will apply.
1. Review & sign the Informed Consent Form
Sign the Informed Consent Form (ICF) before receiving any study drug or study assessments.
2. Confirm you qualify for the study
Visit the clinic for health assessments to confirm if you qualify for the study.
3. Take the study drug
Take the study drug twice per day for 12 weeks (about 3 months).
4. Attend clinic visits
Receive regular assessments at the clinic while you are taking the study drug.
5. Complete a Follow-Up Visit
Visit the clinic for follow-up assessments 4 weeks after your last dose of the study drug.
How to Participate
Please contact 844-511-5437 to find out if you are eligible to participate in the PRONTO-PBC study or submit the following information and you will receive a callback from a PRONTO-PBC team member: