338. 進行性家族性肝内胆汁うっ滞症 Progressive familial intrahepatic cholestasis Clinical trials / Disease details
臨床試験数 : 60 / 薬物数 : 26 - (DrugBank : 6) / 標的遺伝子数 : 2 - 標的パスウェイ数 : 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 | NCT03659916 (ClinicalTrials.gov) | September 28, 2018 | 24/8/2018 | Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) | Progressive Familial Intrahepatic Cholestasis | Drug: A4250 (odevixibat) | Albireo | NULL | Active, not recruiting | 0 Months | 100 Years | All | 120 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom |
| 2 | NCT03566238 (ClinicalTrials.gov) | May 16, 2018 | 25/5/2018 | This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC 1 or 2 | A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1) | PFIC1;PFIC2 | Drug: A4250 (odevixibat);Drug: Placebo | Albireo | NULL | Completed | 6 Months | 18 Years | All | 62 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom |