DDrare: Database of Drug Development for Rare Diseases

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	EUCTR2017-003538-10-NL (EUCTR)	03/09/2018	18/12/2017	Open-Label with BIVV009 in patients with Cold Agglutinin Disease	A PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study	Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR	Bioverativ USA, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 3	United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan
2	EUCTR2017-003539-12-ES (EUCTR)	06/02/2018	07/11/2017	A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza	Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR	Bioverativ USA Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Japan;United States;Spain;Austria

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

EUCTR2017-003538-10-NL
(EUCTR)

03/09/2018

18/12/2017

Open-Label with BIVV009 in patients with Cold Agglutinin Disease

A PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study

Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR

Bioverativ USA, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan

EUCTR2017-003539-12-ES
(EUCTR)

06/02/2018

07/11/2017

A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza

Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR

Bioverativ USA Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Japan;United States;Spain;Austria