Seladelpar 5 mg (DrugBank: -)
1 disease告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
93 | 原発性胆汁性胆管炎[原発性胆汁性肝硬変 (~2017.3)] | 2 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | NCT04620733 (ClinicalTrials.gov) | January 2021 | 4/11/2020 | RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA) | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cholangitis | Drug: Seladelpar 10 mg;Drug: Placebo;Drug: Seladelpar 5 mg | CymaBay Therapeutics, Inc. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 180 | Phase 3 | NULL |
2 | NCT03301506 (ClinicalTrials.gov) | December 12, 2017 | 26/9/2017 | Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) | Primary Biliary Cirrhosis | Drug: Seladelpar 5 mg Capsule;Drug: Seladelpar 10 mg Capsule | CymaBay Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 500 | Phase 3 | United States;Canada;Germany;United Kingdom |