Seladelpar for Primary Biliary Cholangitis
Trial Summary
What is the purpose of this trial?
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you must stop all current medications, but certain medications are prohibited. You must stop using colchicine, methotrexate, azathioprine, long-term systemic steroids, fibrates, obeticholic acid, and any experimental treatments for PBC within specific timeframes before screening. Other medications affecting liver or GI functions may also be prohibited and should be discussed with the medical monitor.
Will I have to stop taking my current medications?
You may need to stop taking certain medications before joining the trial. Specifically, you cannot use colchicine, methotrexate, azathioprine, long-term systemic steroids, fibrates, obeticholic acid, or any experimental treatments for PBC within a few months before the trial. It's best to discuss your current medications with the trial team to see if any need to be adjusted.
What data supports the idea that Seladelpar for Primary Biliary Cholangitis is an effective drug?
The available research shows that Seladelpar is effective for treating Primary Biliary Cholangitis. In a study, patients who did not respond well to the usual treatment, ursodeoxycholic acid, showed improvement when using Seladelpar. Another study found that Seladelpar helped reduce itching, improve sleep, and decrease tiredness in patients. Additionally, a phase 3 study confirmed that Seladelpar was effective and safe compared to a placebo. Overall, these studies suggest that Seladelpar can be a beneficial option for patients who do not respond to other treatments.12345
What data supports the effectiveness of the drug Seladelpar for treating primary biliary cholangitis?
Research shows that Seladelpar, a drug that helps regulate bile acids, improved symptoms like itching and fatigue in patients with primary biliary cholangitis who did not respond well to other treatments. It also showed positive effects on liver function and was generally safe over long-term use.12345
What safety data is available for Seladelpar in treating primary biliary cholangitis?
Seladelpar has been evaluated for safety in multiple clinical trials for primary biliary cholangitis (PBC). These include a phase 2 double-blind, randomized, placebo-controlled study, an open-label phase 2 study, a phase 2 open-label 52-week study, a phase 3 randomized, placebo-controlled study, and a two-year open-label extension study. These studies assessed the safety and efficacy of Seladelpar in patients with PBC, particularly those with an inadequate response or intolerance to ursodeoxycholic acid. The trials demonstrated that Seladelpar is a selective PPAR-δ agonist with anti-cholestatic, anti-inflammatory, and anti-pruritic effects, and they provided safety data over periods ranging from 3 months to 2 years.12345
Is Seladelpar safe for humans?
Is the drug Seladelpar a promising treatment for Primary Biliary Cholangitis?
Yes, Seladelpar is a promising drug for Primary Biliary Cholangitis. It has shown positive effects in improving symptoms like itching and fatigue, and it helps reduce bile acid levels in the blood. Clinical studies have demonstrated its potential to help patients who do not respond well to existing treatments.12346
How is the drug Seladelpar different from other treatments for primary biliary cholangitis?
Research Team
Gilead Study Director
Principal Investigator
Gilead Sciences
Eligibility Criteria
This trial is for individuals who have previously participated in a seladelpar study for Primary Biliary Cholangitis (PBC), are not pregnant or breastfeeding, and agree to use two forms of birth control. It's not open to those with certain liver conditions, kidney issues, cancer within the last 2 years, chronic viral hepatitis, or on specific medications affecting liver function.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive seladelpar to evaluate long-term safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive seladelpar for long-term evaluation
Treatment Details
Interventions
- Seladelpar
Seladelpar is already approved in United States, European Union for the following indications:
- Primary biliary cholangitis
- Primary biliary cholangitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gilead Sciences
Lead Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
CymaBay Therapeutics, Inc.
Lead Sponsor