A Long-Term Study of Elafibranor in Adult Participants with Primary Biliary Cholangitis
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring). PBC is a disease that progresses slowly. It causes damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many people with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment). Each participant will be in the study for about 3.5 years. The main aim of this study is to determine if elafibranor is better than placebo in preventing adverse (bad) clinical outcomes including progression of disease leading to liver transplant or death. This study will also examine the safety of long-term treatment with elafibranor, as well as the impact on symptoms like itching and tiredness.
A Long-Term Study of Elafibranor in Adult Participants with Primary Biliary Cholangitis
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring). PBC is a disease that progresses slowly. It causes damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many people with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment). Each participant will be in the study for about 3.5 years. The main aim of this study is to determine if elafibranor is better than placebo in preventing adverse (bad) clinical outcomes including progression of disease leading to liver transplant or death. This study will also examine the safety of long-term treatment with elafibranor, as well as the impact on symptoms like itching and tiredness.
Related Clinical Trials
![A study to evaluate the effect of phenytoin or itraconazole on the circulating levels of IPN60130 in healthy adult participants A study to evaluate the effect of phenytoin or itraconazole on the circulating levels of IPN60130 in healthy adult participants](https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/defaultImg.png)
A study to evaluate the effect of phenytoin or itraconazole on the circulating levels of IPN60130 in healthy adult participants
![A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ?14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies. A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ?14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.](https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/defaultImg.png)
A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ?14 Years With Fibrodysplasia Ossificans Progressiva...
![A study to assess whether adding maintenance cabozantinib (XL184) to best supportive care helps children, adolescents and young adults with osteosarcoma. A study to assess whether adding maintenance cabozantinib (XL184) to best supportive care helps children, adolescents and young adults with osteosarcoma.](https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/defaultImg.png)
A study to assess whether adding maintenance cabozantinib (XL184) to best supportive care helps children, adolescents and young adults with osteosarcoma.
![A study to evaluate the effectiveness and safety of Dysport® for the prevention of episodic migraine in adults A study to evaluate the effectiveness and safety of Dysport® for the prevention of episodic migraine in adults](https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/defaultImg.png)
A study to evaluate the effectiveness and safety of Dysport® for the prevention of episodic migraine in adults
![A study to evaluate the effectiveness and safety of Dysport® for the prevention of chronic migraine in adults A study to evaluate the effectiveness and safety of Dysport® for the prevention of chronic migraine in adults](https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/defaultImg.png)
A study to evaluate the effectiveness and safety of Dysport® for the prevention of chronic migraine in adults
![A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity. A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.](https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/defaultImg.png)
A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.
![A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours](https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/defaultImg.png)
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
![Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours](https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/defaultImg.png)
Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours
![Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia](https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/defaultImg.png)
Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia
![Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia. Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.](https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/defaultImg.png)