93. 原発性胆汁性胆管炎［原発性胆汁性肝硬変 (~2017.3)］
［臨床試験数：230，薬物数：215（DrugBank：51），標的遺伝子数：34，標的パスウェイ数：107］
Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis", "PBC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | NCT03082937 (ClinicalTrials.gov) | January 31, 2017 | 27/2/2017 | An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects | An Open Label, Single-Dose, Single Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-A4250 in Healthy Male Subjects | Orphan Cholestatic Liver Diseases;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome;Primary Biliary Cirrhosis | Drug: 3 mg [14C]-A4250 capsule | Albireo | NULL | Completed | 30 Years | 65 Years | Male | 6 | Phase 1 | United Kingdom |
| 2 | NCT02360852 (ClinicalTrials.gov) | January 2015 | 14/1/2015 | IBAT Inhibitor A4250 for Cholestatic Pruritus | An Exploratory, Phase IIa Study to Demonstrate the Safety and Efficacy of A4250 in Patients With Primary Biliary Cirrhosis and Cholestatic Pruritus | Biliary Cirrhosis, Primary | Drug: A4250 | Sahlgrenska University Hospital, Sweden | Albireo | Terminated | 18 Years | 80 Years | All | 9 | Phase 2 | Sweden |
| 3 | EUCTR2014-004070-42-SE (EUCTR) | 09/12/2014 | 15/10/2014 | Study to Demonstrate the Efficacy and Safety of A4250 in Patients withPrimary Biliary Cirrhosis and Cholestatic Pruritus | An Exploratory, Phase IIa Cross-Over Study to Demonstrate the Efficacyand Safety of A4250 in Patients with Primary Biliary Cirrhosis andCholestatic Pruritus | Primary biliary cirrhosis complicated by cholestatic pruritus.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: A4250 | Sahlgrenska Academy | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2a | Sweden | |||
| 4 | NCT02963077 (ClinicalTrials.gov) | July 2013 | 1/11/2016 | A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384 | A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of A4250 as Monotherapy, and in Combination With Colonic Release Cholestyramine (A3384) or Commercially Available Cholestyramine (Questran™) in Healthy Subjects | Orphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome | Drug: A4250;Drug: CRC (A3384);Drug: Questran;Drug: Placebo | Albireo | NULL | Completed | 18 Years | 60 Years | Both | 94 | Phase 1 | NULL |