DDrare: Database of Drug Development for Rare Diseases

61. 自己免疫性溶血性貧血
［臨床試験数：90，薬物数：72（DrugBank：23），標的遺伝子数：19，標的パスウェイ数：147］

Searched query = "Autoimmune hemolytic anemia", "AIHA", "WAIHA", "Cold agglutinin disease", "CAD", "Paroxysmal cold hemoglobinuria", "MAIHA", "Evans syndrome"
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 = ALXN1830; ANX005; APL-2; Acalabrutinib; BENDAMUSTINE HYDROCHLORIDE; BIV009; BIVV009; BIVV020; Bendamustine; Bendamustine, Rituximab; Blood sample; Blood samples; Bortezomib; CINRYZE® (C1 esterase inhibitor [human]); COMPLEMENT C1 ESTERASE INHIBITOR; Ciclosporin; Cinryze; Combination of a single dose anti-CD20 antibody and bortezomib; Complement C1 esterase inhibitor; EFALIZUMAB; Eculizumab; Efalizumab; Fludarabine; Fostamatinib; Fostamatinib 150 mg bid; Fostamatinib Disodium; Fostamatinib disodium; INCB050465; INCB050465 1 mg; INCB050465 2.5 mg; INCB050465 HYDROCHLORIDE; Ibrutinib; Interleukine-2; Isatuximab; Isatuximab SAR650984; KZR-616; Levact; Levamisole; M281; MabThera; Ninlaro; ORILANOLIMAB; Orilanolimab; Parsaclisib; Prednisolone; Prednisolone + mabthera; Prednisone; Prednisone, low dose rituximab; Procedure: spleen sample; R788, fostamatinib disodium hexahydrate (in USPI/FPI); R935788; RITUXIMAB; RVT-1401; RVT-1401 340 mg/weekly; RVT-1401 680 mg/weekly; Rapamycin; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Rituximab; Rituximab (MABTHERA® or RITUXAN®).; Rituximab (Mabthera®); SYNT001; Sirolimus; Soliris; Soliris (R); Sutimlimab; Sutimlimab (BIVV009); TNT009; Tacrolimus; Urine sample; VELCADE*EV 1FL 3,5MG 1MG/ML; Velcade

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	NCT04256148 (ClinicalTrials.gov)	July 2021	27/1/2020	ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia	Warm Autoimmune Hemolytic Anemia	Biological: ALXN1830;Other: Placebo	Alexion Pharmaceuticals	NULL	Withdrawn	18 Years	N/A	All	0	Phase 2	United States
2	EUCTR2019-004055-37-ES (EUCTR)	06/05/2020	10/05/2020	ALXN1830 in Patients with Warm Autoimmune Hemolytic Anemia	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients with Warm Autoimmune Hemolytic Anemia	WAIHA MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: ALXN1830 INN or Proposed INN: ORILANOLIMAB Other descriptive name: SYNT001	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	32	Phase 2	United States;Taiwan;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Korea, Republic of
3	NCT03075878 (ClinicalTrials.gov)	January 10, 2018	3/3/2017	A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)	A Phase 1B/2, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Patients With Warm Autoimmune Hemolytic Anemia (WAIHA)	Warm Autoimmune Hemolytic Anemia	Drug: ALXN1830	Alexion Pharmaceuticals	NULL	Terminated	18 Years	N/A	All	8	Phase 1;Phase 2	United States;Jordan

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

NCT04256148
(ClinicalTrials.gov)

July 2021

27/1/2020

ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia

Warm Autoimmune Hemolytic Anemia

Biological: ALXN1830;Other: Placebo

Alexion Pharmaceuticals

NULL

Withdrawn

18 Years

N/A

All

Phase 2

United States

EUCTR2019-004055-37-ES
(EUCTR)

06/05/2020

10/05/2020

ALXN1830 in Patients with Warm Autoimmune Hemolytic Anemia

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients with Warm Autoimmune Hemolytic Anemia

WAIHA
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: ALXN1830
INN or Proposed INN: ORILANOLIMAB
Other descriptive name: SYNT001

Alexion Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Taiwan;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Korea, Republic of

NCT03075878
(ClinicalTrials.gov)

January 10, 2018

3/3/2017

A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)

A Phase 1B/2, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Patients With Warm Autoimmune Hemolytic Anemia (WAIHA)

Warm Autoimmune Hemolytic Anemia

Drug: ALXN1830

Alexion Pharmaceuticals

NULL

Terminated

18 Years

N/A

All

Phase 1;Phase 2

United States;Jordan