93. Primary biliary cholangitis Clinical trials / Disease details
Clinical trials : 298 / Drugs : 252 - (DrugBank : 59) / Drug target genes : 35 - Drug target pathways : 115
| 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-UMIN000031384 | 2018/03/16 | 20/02/2018 | Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study) | Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study) - Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study) | PBC patients with osteoporosis | Denosumab group (60 mg Denosumab is administered subcutaneously every 6 month) Zoledronic acid group (5 mg Zoledronic acid is administered intravenously every 12 month) | Tokai University School of Medicine | Ministry of Health, Labour and Welfare | Complete: follow-up complete | 20years-old | 89years-old | Male and Female | 80 | Not selected | Japan |
| 2 | JPRN-UMIN000012489 | 2013/12/04 | 04/12/2013 | Efficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosis | Efficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosis - Efficacy of Denosumab for osteoporosis patients with PBC | Osteoporosis in biopsy-proven PBC who was not pretreated with denosumab and/or bisphosphonate in recent 6 months | For osteoporosis patients who need treatment based on PBC treatment guideline, 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. PBC patients who do not meet osteoporosis treatment criteria will be followed. | Juntendo University School of Medicine | NULL | Complete: follow-up continuing | 20years-old | Not applicable | Male and Female | 20 | Not applicable | Japan |
| 3 | JPRN-UMIN000012193 | 2013/11/01 | 01/11/2013 | Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis | Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis - Denosumab versus Bisphosphonate for osteoporosis in patients with PBC | Osteoporosis in biopsy-proven primary biliary cirrhosis patients pretreated with bisphosphonate | Discontinue the administration of aredoron acid, risedronic acid, and 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. Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D. | Juntendo University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 60 | Not applicable | Japan |