95. 自己免疫性肝炎 Autoimmune hepatitis Clinical trials / Disease details
臨床試験数 : 52 / 薬物数 : 68 - (DrugBank : 27) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 111
| 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 | JPRN-UMIN000013659 | 2014/04/08 | 08/04/2014 | Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH) | Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH) - Efficacy of Denosumab for steroid-induced osteoporosis in patients with AIH | Biopsy-proven AIH patients who are planned or undergoing oral steroid therapy for more than 3 months | <Test A; Randomization test: 1)2)> In patients pretreated with bisphosphonates; 1) Discontinue the administration of aredoron acid, risedronic acid, or minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately. <Test A; Randomization test: 1)2)> 2) Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D. <Test B; newly intervention> In patients who were not pretreated with bisphosphonates; 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately. | Juntendo University School of Medicine | NULL | Complete: follow-up continuing | 20years-old | 75years-old | Male and Female | 80 | Not applicable | Japan |