A study to evaluate the safety and effectiveness of an investigational drug, seladelpar, in treating patients with primary biliary cholangitis (PBC).
About this study
Primary biliary cholangitis (PBC) is a chronic disease in which the bile ducts in your liver are slowly destroyed. Human studies have shown that seladelpar may be useful for treating the signs and symptoms of PBC and lower alkaline phosphatase (AP) level and decrease itching.
Anticipated enrolment close date: 31 December 2020
Who can take part
Inclusion criteria
- 18 to 75 years old (inclusive)
- On a stable and recommended dose of UDCA for the past twelve months OR intolerant to UDCA
Exclusion criteria
- Previous exposure to seladelpar (MBX-8025)
- Have had a liver transplant
What's involved
- Medical history
- Physical exam
- Electrocardiogram (ECG)
- Weight
- Height
- Blood pressure
- Pulse
- Heart rate
- Health questionnaires
- Abdominal ultrasound
- Liver biopsy (optional)
- Blood samples
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.