DDrare: Database of Drug Development for Rare Diseases

Searched query = "Autoimmune hepatitis"
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.

Drug = AZATHIOPRINE; Abatacept; Anti-BAFFR antibody; Anti-BAFFr antibody; Azathioprine; Budesonide; Calcium; Cannabidiol; Chloroquine; Chloroquine diphosphate; Chloroquine diphosphate 250mg; Cyclosporin; Cyclosporin A; Cyclosporine; Cyclosporine-A; Denosumab; EFALIZUMAB; Efalizumab; Erythropoietin; Gold; High protein high fiber diet; INTERLEUKIN 2; Ianalumab; Inflectra (Infliximab); Infliximab; Interleukin 2; JKB-122; JKB-122 in capsule or tablet form; LCP-Tacro (tacrolimus); MYCOPHENOLATE MOFETIL; Metronidazole; Minodronic acid; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofeti; Mycophenolate mofetil; Orbcel-C; Orencia® (Abatacept); PREDNISOLONE SODIUM SUCCINATE; Prednisolone; Prednisone; Preimplantation factor; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Regulatory T cells; Risedronic acid; SPIF; Synthetic PreImplantation Factor; Tacrolimus; Treatment with azathioprin; Treatment with mycophenolat mofetil; Ursodeoxycholic Acid; Ursodeoxycholic acid; Ursodeoxycholic acid combination of immunosuppressive agents; VAY736; Vitamin D; Zoledronic acid

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)		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

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

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)

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

Not applicable

Japan