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	EUCTR2019-003924-19-HU (EUCTR)	07/10/2020	17/08/2020	Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia	A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA	Warm Autoimmune Hemolytic Anemia 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 Name: RVT-1401 Product Code: RVT-1401 INN or Proposed INN: RVT-1401 Other descriptive name: RVT-1401	Immunovant Sciences GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	16	Phase 2	United States;Hungary;Thailand;Spain;Israel;United Kingdom;Korea, Republic of
2	NCT04253236 (ClinicalTrials.gov)	August 11, 2020	21/1/2020	To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).	A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients With Warm Autoimmune Hemolytic Anemia	Warm Autoimmune Hemolytic Anemia	Drug: RVT-1401 680 mg/weekly;Drug: RVT-1401 340 mg/weekly	Immunovant Sciences GmbH	NULL	Recruiting	18 Years	N/A	All	16	Phase 2	United States;Israel;Korea, Republic of;Spain;Thailand;United Kingdom
3	EUCTR2019-003924-19-ES (EUCTR)	25/05/2020	14/01/2020	Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia	A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA	Warm Autoimmune Hemolytic Anemia 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 Name: RVT-1401 Product Code: RVT-1401 INN or Proposed INN: RVT-1401 Other descriptive name: RVT-1401	Immunovant Sciences GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	16	Phase 2	United States;Hungary;Thailand;Spain;Romania;Israel;United Kingdom;Korea, Republic of
4	EUCTR2019-003924-19-GB (EUCTR)	26/02/2020	13/03/2020	Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia	A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA	Warm Autoimmune Hemolytic Anemia 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 Name: RVT-1401 Product Code: RVT-1401 INN or Proposed INN: RVT-1401 Other descriptive name: RVT-1401	Immunovant Sciences GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	16	Phase 2	United States;Thailand;Spain;Romania;Israel;United Kingdom;Korea, Republic of

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

EUCTR2019-003924-19-HU
(EUCTR)

07/10/2020

17/08/2020

Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia

A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA

Warm Autoimmune Hemolytic Anemia
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 Name: RVT-1401
Product Code: RVT-1401
INN or Proposed INN: RVT-1401
Other descriptive name: RVT-1401

Immunovant Sciences GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Hungary;Thailand;Spain;Israel;United Kingdom;Korea, Republic of

NCT04253236
(ClinicalTrials.gov)

August 11, 2020

21/1/2020

To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).

A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients With Warm Autoimmune Hemolytic Anemia

Warm Autoimmune Hemolytic Anemia

Drug: RVT-1401 680 mg/weekly;Drug: RVT-1401 340 mg/weekly

Immunovant Sciences GmbH

NULL

Recruiting

18 Years

N/A

All

Phase 2

United States;Israel;Korea, Republic of;Spain;Thailand;United Kingdom

EUCTR2019-003924-19-ES
(EUCTR)

25/05/2020

14/01/2020

Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia

A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA

Product Name: RVT-1401
Product Code: RVT-1401
INN or Proposed INN: RVT-1401
Other descriptive name: RVT-1401

Immunovant Sciences GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Hungary;Thailand;Spain;Romania;Israel;United Kingdom;Korea, Republic of

EUCTR2019-003924-19-GB
(EUCTR)

26/02/2020

13/03/2020

Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia

A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA

Product Name: RVT-1401
Product Code: RVT-1401
INN or Proposed INN: RVT-1401
Other descriptive name: RVT-1401

Immunovant Sciences GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Thailand;Spain;Romania;Israel;United Kingdom;Korea, Republic of