61. 自己免疫性溶血性貧血 Autoimmune hemolytic anemia Clinical trials / Disease details


臨床試験数 : 137 薬物数 : 127 - (DrugBank : 55) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 153

  
No.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Status
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agemin
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agemax
Inclusion_
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PhaseCountries
1NCT05073458
(ClinicalTrials.gov)
March 15, 202228/9/2021Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic AnemiaA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic AnemiaWarm Autoimmune Hemolytic Anemia (wAIHA)Drug: parsaclisinib;Drug: placeboIncyte CorporationNULLRecruiting18 Years99 YearsAll100Phase 3United States;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Spain;United Kingdom
2EUCTR2021-002844-66-NL
(EUCTR)
10/03/202229/11/2021Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic AnemiaA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia Primary 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: Parsaclisib (1 mg)
Product Code: INCB050465
INN or Proposed INN: not yet assigned
Other descriptive name: INCB050465 HYDROCHLORIDE
Product Name: Parsaclisib (2.5 mg)
Product Code: INCB050465
INN or Proposed INN: not yet assigned
Other descriptive name: INCB050465 HYDROCHLORIDE
Incyte CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Canada;Belgium;Poland;Netherlands;Germany;Japan
3NCT05221619
(ClinicalTrials.gov)
February 10, 20225/1/2022Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)Nipocalimab Post-trial Access in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) Who Are Experiencing Clinical Benefit After Complete 28-Weeks Open-label Extension in MOM-M281-006Anemia, Hemolytic, AutoimmuneDrug: NipocalimabJanssen Research & Development, LLCNULLAvailableN/AN/AAllNULL
4EUCTR2021-002039-40-IT
(EUCTR)
08/02/202201/10/2021Basket study to assess efficacy, safety and PK of iptacopan (LNP023) in autoimmune benign hematological disordersAn open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders - -- Immune thrombocytopenia (ITP)Cold agglutinin disease (CAD)
MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10068863;Term: Cold agglutinin disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml
Product Name: -
Product Code: [-]
INN or Proposed INN: HAEMOPHILUS INFLUENZAE
Trade Name: BEXSERO – Sospensione iniettabile – Siringa preriempita
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO CONTRO IL MEMINGOCOCCO DI GRUPPO B
Trade Name: HIBERIX - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE 1 FLACONCINO DI POLVERE + 1 SIRINGA PRERIEMPITA DI SOLVENTE DA 0.5 ML
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO HAEMOPHILUS INFLUENZAE B CONIUGATO CON TOSSOIDETETANICO
Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135)
Trade Name: Nimenrix
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135)
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;Spain;Korea, Democratic People's Republic of;Germany;United Kingdom;Italy
5NCT05089227
(ClinicalTrials.gov)
February 3, 202211/10/2021Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter StudyEfficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter StudyProlonged Anticoagulation;Venous Thromboembolic Disease;Autoimmune Hemolytic AnemiaDrug: treatment intervention;Drug: treatment standard;Biological: biological assessmentCentre Hospitalier Universitaire DijonNULLRecruiting18 YearsN/AAll72Phase 2France
6EUCTR2021-002844-66-ES
(EUCTR)
03/02/202215/10/2021Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic AnemiaA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia Primary 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: Parsaclisib (1 mg)
Product Code: INCB050465
INN or Proposed INN: Parsaclisib
Other descriptive name: INCB050465 HYDROCHLORIDE
Product Name: Parsaclisib (2.5 mg)
Product Code: INCB050465
INN or Proposed INN: Parsaclisib
Other descriptive name: INCB050465 HYDROCHLORIDE
Incyte CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;Japan
7NCT04956276
(ClinicalTrials.gov)
January 1, 202230/6/2021Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic AnemiaA Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study of ALXN1830 Administered Subcutaneously in Patients With Warm Autoimmune Hemolytic Anemia (WAIHA)Warm Autoimmune Hemolytic AnemiaDrug: ALXN1830;Drug: PlaceboAlexion PharmaceuticalsNULLWithdrawn18 YearsN/AAll0Phase 2United States
8JPRN-jRCT2051210140
30/12/202124/12/2021A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic AnemiaA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia - PATHWAY Warm Autoimmune Hemolytic Anemia (wAIHA)Group A: Parsaclisib (INCB050465) will be administered QD orally.
Group B: Placebo will be administered QD orally.
Ueda EijiNULLRecruiting>= 18age old<= 99age oldBoth100Phase 3U.S.A;Japan
9NCT05086744
(ClinicalTrials.gov)
December 21, 202128/9/2021Basket Study to Assess Efficacy, Safety and PK of Iptacopan (LNP023) in Autoimmune Benign Hematological DisordersAn Open-label, Multi-center, Phase 2 Basket Study to Assess Efficacy, Safety and Pharmacokinetics of Iptacopan (LNP023) in Participants With Autoimmune Benign Hematological DisordersImmune Thrombocytopenia (ITP);Cold Agglutinin Disease (CAD)Drug: IptacopanNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll30Phase 2Germany;Spain;United Kingdom
10JPRN-jRCT2031210392
07/12/202127/10/2021Sutimlimab (BIVV009) for the adult participants with cold agglutinin disease (CAD) who have completed Phase 3 studies (CARDINAL or CADENZA) in JapanAn open-label study for sutimlimab in participants with cold agglutinin disease (CAD) who have completed the CARDINAL study (BIVV009-03/EFC16215, Part B) or CADENZA study (BIVV009-04/EFC16216, Part B) in Japan Cold Agglutinin DiseaseDrug: sutimlimab (BIVV009)
Pharmaceutical Form: solution for injection, Route of Administration: intravenous(iv)
Tanaka TomoyukiNULLNot Recruiting>= 20age oldNot applicableBoth7Phase 3Japan
11NCT05002777
(ClinicalTrials.gov)
December 7, 20215/8/2021Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic AnemiaWarm Autoimmune Hemolytic Anemia (wAIHA)Drug: rilzabrutinibSanofiNULLRecruiting18 YearsN/AAll20Phase 2United States;China;Denmark;Italy;Spain;United Kingdom
12EUCTR2021-002844-66-IT
(EUCTR)
23/11/202123/09/2021Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic AnemiaA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia - NA Primary 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: Parsaclisib (1 mg)
Product Code: [INCB050465]
Other descriptive name: INCB050465 HYDROCHLORIDE
Product Name: Parsaclisib (2.5 mg)
Product Code: [INCB050465]
Other descriptive name: INCB050465 HYDROCHLORIDE
Product Name: trimethoprim-sulfamethoxazole
Product Code: [trimethoprim-sulfamethoxazole]
INN or Proposed INN: TRIMETOPRIM + SULFAMETOSSAZOLO *
Product Name: pentamidine
Product Code: [pentamidine]
INN or Proposed INN: PENTAMIDINA ISETIONATO
Product Name: atovaquone
Product Code: [atovaquone]
INN or Proposed INN: ATOVAQUONE
INCYTE CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Germany;Netherlands;Japan
13EUCTR2021-001671-16-DK
(EUCTR)
15/11/202116/07/2021Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemiaA multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia Warm autoimmune hemolytic anemia
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: Rilzabrutinib
Product Code: SAR444671
INN or Proposed INN: Rilzabrutinib
Other descriptive name: PRN1008
Sanofi aventis recherche et developpementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;Spain;Denmark;United Kingdom;Italy;China
14NCT05132127
(ClinicalTrials.gov)
November 11, 202111/11/2021Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in JapanAn Open-label Study for Sutimlimab in Participants With Cold Agglutinin Disease (CAD) Who Have Completed the CARDINAL Study (BIVV009-03/EFC16215, Part B) or CADENZA Study (BIVV009-04/EFC16216, Part B) in JapanCold Agglutinin DiseaseDrug: sutimlimabSanofiNULLActive, not recruiting20 YearsN/AAll7Phase 3Japan
15EUCTR2021-002039-40-ES
(EUCTR)
02/11/202103/11/2021Basket study to assess efficacy, safety and PK of iptacopan (LNP023) in autoimmune benign hematological disordersAn open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders Immune thrombocytopenia (ITP)Cold agglutinin disease (CAD)
MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10068863;Term: Cold agglutinin disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of
16EUCTR2021-002039-40-DE
(EUCTR)
29/10/202114/09/2021Basket study to assess efficacy, safety and PK of iptacopan (LNP023) in autoimmune benign hematological disordersAn open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders Immune thrombocytopenia (ITP)Cold agglutinin disease (CAD)
MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10068863;Term: Cold agglutinin disease;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of
17EUCTR2020-003675-18-BG
(EUCTR)
28/10/202129/07/2021Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHAA Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia 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] - Blood and lymphatic diseases [C15]
Product Code: ANX005
INN or Proposed INN: ANX005
Other descriptive name: ANX005
Annexon, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;France;Czechia;Spain;Austria;Australia;Bulgaria;Germany;Italy
18NCT05057468
(ClinicalTrials.gov)
October 20, 202116/9/2021Second-line Treatment of Primary Autoimmune Hemolytic AnemiaCyclosporine as a Second-line Treatment of Primary Autoimmune Hemolytic AnemiaPrimary Autoimmune Hemolytic AnemiaDrug: Cyclosporine;Drug: RituximabAssiut UniversityNULLRecruiting18 YearsN/AAll30Phase 3Egypt
19NCT05263817
(ClinicalTrials.gov)
October 8, 20211/12/2021A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and VasculitisA Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and VasculitisPOEMS Syndrome;Amyloidosis;Autoimmune Hemolytic Anemia;VasculitisBiological: CD19/BCMA CAR T-cellsZhejiang UniversityYake Biotechnology Ltd.RecruitingN/AN/AAll75Early Phase 1China
20EUCTR2021-001671-16-ES
(EUCTR)
08/10/202123/06/2021Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemiaA multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia Warm autoimmune hemolytic anemia
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: Rilzabrutinib
Product Code: SAR444671
INN or Proposed INN: Rilzabrutinib
Other descriptive name: PRN1008
Sanofi aventis recherche et developpementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;Spain;Denmark;United Kingdom;Italy;China
21EUCTR2021-001671-16-IT
(EUCTR)
24/09/202112/10/2021Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warmautoimmune hemolytic anemiaA multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia - . Warm autoimmune hemolytic anemia
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: Rilzabrutinib
Product Code: [SAR444671]
INN or Proposed INN: Rilzabrutinib
Other descriptive name: PRN1008
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;Spain;Denmark;United Kingdom;China;Italy
22NCT05057481
(ClinicalTrials.gov)
September 15, 202116/9/2021Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus ErythematosusReappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus ErythematosusAutoimmune Hemolytic Anemia;Systemic Lupus ErythematosusDrug: Mycophenolate Mofetil 500mg;Drug: RituximabAssiut UniversityNULLActive, not recruiting18 YearsN/AAll30Phase 3Egypt
23NCT04661033
(ClinicalTrials.gov)
September 9, 20211/12/2020Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)A Multicenter, Open-label, Non-randomized, Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic AnemiaWarm Autoimmune Hemolytic Anemia (wAIHA)Drug: Isatuximab SAR650984SanofiNULLRecruiting18 YearsN/AAll23Phase 1/Phase 2United States;Belgium;France;Germany;Hungary;Italy;Netherlands;United Kingdom
24EUCTR2021-001211-90-IT
(EUCTR)
26/08/202122/10/2021ALXN1830 in Patients with Warm Autoimmune Hemolytic AnemiaA Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo- Controlled Study of ALXN1830 Administered Subcutaneously in Patients with Warm Autoimmune Hemolytic Anemia (WAIHA) - N/A 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 Name: ALXN1830
Product Code: [N/A]
INN or Proposed INN: ORILANOLIMAB
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
36Phase 2France;United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of
25EUCTR2021-001211-90-ES
(EUCTR)
11/08/202102/07/2021ALXN1830 in Patients with Warm Autoimmune Hemolytic AnemiaA Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study of ALXN1830 Administered Subcutaneously in Patients with Warm Autoimmune Hemolytic Anemia (WAIHA) 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 Name: ALXN1830
INN or Proposed INN: ORILANOLIMAB
Other descriptive name: SYNT001
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2France;United States;Spain;Germany;United Kingdom;Italy;Korea, Republic of
26NCT04256148
(ClinicalTrials.gov)
July 202127/1/2020ALXN1830 in Patients With Warm Autoimmune Hemolytic AnemiaA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients With Warm Autoimmune Hemolytic AnemiaWarm Autoimmune Hemolytic AnemiaBiological: ALXN1830;Other: PlaceboAlexion PharmaceuticalsNULLWithdrawn18 YearsN/AAll0Phase 2United States
27EUCTR2020-003880-24-NL
(EUCTR)
09/06/202103/02/2021Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemiaA multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Isatuximab
Product Code: SAR650984
INN or Proposed INN: Isatuximab
Other descriptive name: SAR650984
Sanofi-Aventis Recherche & DeveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 1;Phase 2France;United States;Hungary;Belgium;Germany;Netherlands;United Kingdom;Italy
28EUCTR2020-003880-24-IT
(EUCTR)
07/06/202104/06/2021Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemiaA multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia - . Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Montelukast
Product Code: [.]
INN or Proposed INN: MONTELUKAST
Product Name: Isatuximab
Product Code: [SAR650984]
INN or Proposed INN: Isatuximab
Product Name: Paracetamolo
Product Code: [.]
INN or Proposed INN: PARACETAMOLO
Product Name: Famotidina
Product Code: [.]
INN or Proposed INN: FAMOTIDINA
Product Name: Levocitirizina
Product Code: [.]
INN or Proposed INN: LEVOCETIRIZINA DICLORIDRATO
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 1;Phase 2France;United States;Hungary;Belgium;Netherlands;Germany;United Kingdom;Italy
29ChiCTR2100045594
2021-04-192021-04-19A single center prospective clinical study of Orelabrutinib in the treatment of relapsed/refractory autoimmune hemolytic anemia/Evans syndromeA single center prospective clinical study of Orelabrutinib in the treatment of recurrent refractory autoimmune hemolytic anemia/Evans syndrome Relapsed/refractory autoimmune hemolytic anemia /Evans syndromeSingle arm:Orelabrutinib;Tianjin Medical University General HospitalNULLRecruitingBothSingle arm:20;Phase 4China
30EUCTR2019-001882-34-NL
(EUCTR)
06/04/202105/01/2021This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057.A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Bulgaria;Georgia;Norway;Germany;Netherlands
31EUCTR2020-003880-24-DE
(EUCTR)
24/03/202114/12/2020Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmunehemolytic anemiaA multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Isatuximab
Product Code: SAR650984
INN or Proposed INN: Isatuximab
Other descriptive name: SAR650984
Sanofi-Aventis Recherche & DeveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 1;Phase 2France;United States;Hungary;Belgium;Netherlands;Germany;United Kingdom;Italy
32NCT04802057
(ClinicalTrials.gov)
March 22, 202115/3/2021Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With BIVV020An Open Label, Long Term, Safety and Tolerability Study of Patients With Cold Agglutinin Disease Previously Treated With BIVV020Autoimmune Haemolytic AnaemiaDrug: BIVV020Bioverativ, a Sanofi companyNULLActive, not recruiting18 YearsN/AAll4Phase 1Germany;Italy;Netherlands;Norway;United Kingdom
33EUCTR2020-003880-24-HU
(EUCTR)
18/03/202128/01/2021Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmunehemolytic anemiaA multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Isatuximab
Product Code: SAR650984
INN or Proposed INN: Isatuximab
Other descriptive name: SAR650984
Sanofi-Aventis Recherche & DeveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 1;Phase 2France;United States;Hungary;Belgium;Netherlands;Germany;United Kingdom;Italy
34NCT04657094
(ClinicalTrials.gov)
March 16, 20211/12/2020Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic LeukemiaA Phase 2 Trial of Acalabrutinib for the Treatment of Relapsed/Refractory Autoimmune Hemolytic AnemiaAutoimmune Hemolytic Anemia;Chronic Lymphocytic Leukemia;Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma;Warm Antibody Autoimmune Hemolytic AnemiaDrug: AcalabrutinibCity of Hope Medical CenterNational Cancer Institute (NCI)Recruiting18 YearsN/AAll22Phase 2United States
35EUCTR2020-005854-90-AT
(EUCTR)
11/02/202105/01/2021Investigation of the influence of ANX005 on the body of patients with primary cold agglutinin disease in terms of safety and tolerability. A Phase 2, single-center, open-label, repeat-dose study.A Phase 2, Single-Center, Open-Label, Repeat-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of Intravenous ANX005 in Participants with Primary Cold Agglutinin Disease Primary Cold Agglutinin Disease (CAD);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: ANX005
INN or Proposed INN: ANX005
Other descriptive name: Recombinant humanized IgG4 monoclonal antibody
Annexon, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
6Phase 2Austria
36EUCTR2020-003675-18-AT
(EUCTR)
05/02/202110/12/2020Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHAA Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia 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] - Blood and lymphatic diseases [C15]
Product Code: ANX005
INN or Proposed INN: ANX005
Other descriptive name: ANX005
Annexon, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;United States;Czechia;Spain;Australia;Austria;Bulgaria;Germany;United Kingdom;Italy
37EUCTR2020-003675-18-DE
(EUCTR)
11/01/202128/09/2020Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHAA Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia 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] - Blood and lymphatic diseases [C15]
Product Code: ANX005
INN or Proposed INN: ANX005
Other descriptive name: ANX005
Annexon, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;United States;Czechia;Spain;Austria;Australia;Bulgaria;Germany;United Kingdom;Italy
38EUCTR2019-003924-19-BG
(EUCTR)
29/12/202023/09/2020Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic AnemiaA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
16Phase 2United States;Hungary;Poland;Spain;Thailand;Israel;Bulgaria;United Kingdom;Korea, Republic of
39EUCTR2020-003675-18-IT
(EUCTR)
11/12/202002/08/2021Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHAA Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia - Study with intravenous ANX005 in patients with 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] - Blood and lymphatic diseases [C15]
Product Name: ANX005
Product Code: [ANX005]
Other descriptive name: Recombinant humanized monoclonal antibody: IgG4 (heavy chain); kappa (light chain)
Annexon, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;Hungary;Spain;Austria;Norway;Netherlands;Germany;United Kingdom;Italy
40EUCTR2019-003924-19-PL
(EUCTR)
04/11/202025/08/2020Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic AnemiaA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
16Phase 2Bulgaria;Israel;United Kingdom;Korea, Republic of;United States;Hungary;Thailand;Spain;Poland
41EUCTR2019-003924-19-HU
(EUCTR)
07/10/202017/08/2020Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic AnemiaA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
16Phase 2United States;Hungary;Poland;Thailand;Spain;Bulgaria;Israel;United Kingdom;Korea, Republic of
42NCT04253236
(ClinicalTrials.gov)
August 11, 202021/1/2020To 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 AnemiaWarm Autoimmune Hemolytic AnemiaDrug: RVT-1401 680 mg/weekly;Drug: RVT-1401 340 mg/weeklyImmunovant Sciences GmbHNULLTerminated18 YearsN/AAll5Phase 2United States;Israel;Korea, Republic of;Spain;Thailand;United Kingdom
43EUCTR2019-001882-34-DE
(EUCTR)
23/07/202013/01/2020This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057.A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany
44NCT04039477
(ClinicalTrials.gov)
July 202026/7/2019A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITPA Phase 2 Randomized, Dose-blind, Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Autoimmune Hemolytic Anemia (AIHA) and Immune Thrombocytopenia (ITP)Autoimmune Hemolytic Anemia;Immune ThrombocytopeniaDrug: KZR-616Kezar Life Sciences, Inc.NULLWithdrawn18 YearsN/AAll0Phase 2United States;Australia;Italy;Poland;Russian Federation
45NCT04269551
(ClinicalTrials.gov)
June 15, 202029/1/2020A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin DiseaseA Multicenter, Phase 1b, Open Label, Nonrandomized, Single Dose Study Evaluating the Safety, Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin DiseaseAutoimmune Haemolytic AnaemiaDrug: BIVV020Bioverativ, a Sanofi companyNULLCompleted18 YearsN/AAll12Phase 1United States;Germany;Italy;Netherlands;Norway;United Kingdom;Canada;Spain
46EUCTR2019-001882-34-DK
(EUCTR)
03/06/202020/01/2020This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057.A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Denmark;Australia;Georgia;Bulgaria;Norway;Netherlands;Germany
47EUCTR2019-003924-19-ES
(EUCTR)
25/05/202014/01/2020Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic AnemiaA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
16Phase 2United States;Hungary;Poland;Thailand;Spain;Romania;Bulgaria;Israel;United Kingdom;Korea, Republic of
48EUCTR2019-001882-34-IT
(EUCTR)
19/05/202030/07/2021This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057.A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia - C-935788-058 Warm antibody 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 Name: Fostamatinib Disodium
Product Code: [R935788]
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: [R935788]
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
RIGEL PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3Belarus;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany
49EUCTR2019-004055-37-ES
(EUCTR)
06/05/202010/05/2020ALXN1830 in Patients with Warm Autoimmune Hemolytic AnemiaA 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.NULLNot RecruitingFemale: yes
Male: yes
32Phase 2Korea, Republic of;Netherlands;Germany;Australia;Belgium;Canada;France;United Kingdom;Italy;Russian Federation;Spain;Taiwan;United States
50EUCTR2019-001882-34-FR
(EUCTR)
05/05/202006/02/2020This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057.A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany
51NCT04398459
(ClinicalTrials.gov)
May 1, 202018/5/2020The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic AnemiaA Phase II, Single-Center, Open-label Trial to Determine the Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune HemolyticRefractory/Relapsed Autoimmune Hemolytic AnemiaDrug: IbrutinibInstitute of Hematology & Blood Diseases HospitalNULLRecruiting6 Years70 YearsAll18Phase 2China
52EUCTR2018-004774-97-NL
(EUCTR)
09/04/202009/10/2019This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen.A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3Serbia;United States;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Germany;Netherlands
53EUCTR2019-000720-17-NL
(EUCTR)
31/03/202016/09/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Netherlands;Germany
54EUCTR2019-003924-19-GB
(EUCTR)
26/02/202013/03/2020Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic AnemiaA 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2United States;Thailand;Spain;Romania;Israel;United Kingdom;Korea, Republic of
55EUCTR2019-001882-34-HU
(EUCTR)
25/02/202027/02/2020This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057.A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany
56EUCTR2019-001882-34-AT
(EUCTR)
24/02/202015/01/2020This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057.A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Serbia;Belarus;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Bulgaria;Georgia;Germany;Netherlands;Norway
57EUCTR2019-001882-34-CZ
(EUCTR)
30/01/202020/12/2019A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Serbia;Belarus;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Georgia;Bulgaria;Norway;Germany;Netherlands
58EUCTR2019-001882-34-ES
(EUCTR)
28/01/202002/12/2019This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057.A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
81 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany
59EUCTR2019-001882-34-GB
(EUCTR)
20/01/202010/12/2019This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057.A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany
60EUCTR2019-000720-17-DE
(EUCTR)
14/01/202005/09/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
61EUCTR2019-000720-17-GR
(EUCTR)
27/12/201908/10/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
148Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
62EUCTR2018-004774-97-DK
(EUCTR)
15/11/201920/06/2019This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen.A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3Norway;Netherlands;Germany;Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Denmark;Australia;Georgia;Bulgaria
63EUCTR2019-000720-17-HU
(EUCTR)
05/11/201906/11/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.0;Level: LLT;Classification code 10073784;Term: Anemia hemolytic autoimmune;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
64NCT04138927
(ClinicalTrials.gov)
October 30, 201923/10/2019A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic AnemiaA Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic AnemiaWarm Antibody Autoimmune Hemolytic AnemiaDrug: Fostamatinib disodiumRigel PharmaceuticalsNULLEnrolling by invitation18 Years100 YearsAll90Phase 3United States;Australia;Austria;Belarus;Belgium;Bulgaria;Czechia;France;Georgia;Germany;Italy;Netherlands;Norway;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
65NCT04119050
(ClinicalTrials.gov)
October 24, 201918/9/2019Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label ExtensionWarm Autoimmune Hemolytic AnemiaDrug: M281;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 YearsN/AAll111Phase 2/Phase 3United States;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Netherlands;Poland;Spain;Ukraine;United Kingdom
66EUCTR2018-004774-97-GB
(EUCTR)
23/10/201904/06/2019This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen.A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany
67EUCTR2018-004774-97-IT
(EUCTR)
16/10/201922/01/2021This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen.A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia - C-935788-057 Warm antibody 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]
Trade Name: na
Product Name: Fostamatinib Disodium
Product Code: [R935788]
INN or Proposed INN: Fostamatinib
Product Name: Fostamatinib Disodium
Product Code: [R935788]
INN or Proposed INN: Fostamatinib
RIGEL PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Denmark;Australia;Georgia;Bulgaria;Norway;Netherlands;Germany
68EUCTR2019-000720-17-FR
(EUCTR)
15/10/201917/09/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2;Phase 3Netherlands;Germany;United Kingdom;Italy;United States;France;Hungary;Czech Republic;Greece;Spain;Poland;Denmark
69EUCTR2018-004774-97-DE
(EUCTR)
10/10/201926/06/2019This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen.A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany
70EUCTR2019-000720-17-PL
(EUCTR)
09/10/201927/09/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: Not Applicable
Other descriptive name: Nipocalimab
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
71EUCTR2018-004774-97-BE
(EUCTR)
30/09/201909/08/2019This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen.A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany
72EUCTR2018-004774-97-AT
(EUCTR)
27/09/201927/06/2019This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen.A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany
73EUCTR2019-000720-17-ES
(EUCTR)
19/09/201927/09/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2;Phase 3France;United States;Hungary;Czech Republic;Greece;Poland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom
74EUCTR2019-000720-17-IT
(EUCTR)
16/09/201927/01/2021Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study with a Long-term Open-label Extension - --- Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: [M281]
INN or Proposed INN: M281
Other descriptive name: M281
MOMENTA PHARMACEUTICALS, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
75EUCTR2019-000720-17-CZ
(EUCTR)
10/09/201910/09/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 2;Phase 3Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands;United States;Czechia;Greece;Spain
76EUCTR2018-004774-97-ES
(EUCTR)
09/09/201911/06/2019This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen.A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
81 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany
77EUCTR2018-004774-97-BG
(EUCTR)
05/09/201904/06/2019This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen.A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Serbia;Belarus;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany
78EUCTR2018-004774-97-CZ
(EUCTR)
05/09/201913/06/2019This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen.A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany
79NCT03965624
(ClinicalTrials.gov)
September 1, 201924/5/2019Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune CytopeniaA Prospective Open-label Trial to Assess the Efficacy and Safety of Ixazomib and Dexamethasone in Patients With Refractory Autoimmune CytopeniaImmune Thrombocytopenia;Warm Autoimmune Hemolytic AnemiaDrug: NinlaroAssistance Publique - Hôpitaux de ParisTakeda Pharmaceuticals International, Inc.Withdrawn18 YearsN/AAll0Phase 2France
80NCT04083014
(ClinicalTrials.gov)
August 20, 201931/8/2019Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic AnemiaAn Open, One-arm, Prospective Study of a Single Dose Anti-CD20 Monoclonal Antibody Combined With Bortezomib for Treatment of Relapsed Refractory Autoimmune Hemolytic AnemiaAutoimmune Hemolytic Anemia;Autoimmune Hemolytic Anemia and Autoimmune ThrombocytopeniaDrug: combination of a single dose anti-CD20 antibody and bortezomibPeking Union Medical College HospitalNULLRecruiting18 Years80 YearsAll43Phase 2China
81EUCTR2018-004774-97-HU
(EUCTR)
06/08/201917/06/2019This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen.A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Warm antibody 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 Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Product Name: Fostamatinib Disodium
Product Code: R935788
INN or Proposed INN: Fostamatinib
Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI)
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Russian Federation;Serbia;United States;Belarus;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany;Ukraine
82ChiCTR1900023476
2019-07-012019-05-30Multicenter, prospective and open clinical study for rapamycin in the treatment of autoimmune hemolytic anemiaMulticenter, prospective and open clinical study for rapamycin in the treatment of autoimmune hemolytic anemia Autoimmune1:glucocorticoid;2:glucocorticoid & Ciclosporin;3:glucocorticoid & rapamycin;4:rapamycin;Tianjin Medical University General HospitalNULLPendingBoth1:20;2:20;3:20;4:20;China
83NCT03918265
(ClinicalTrials.gov)
May 4, 201916/4/2019Tacrolimus Treatment for Refractory Autoimmune CytopeniaTacrolimus Treatment for Refractory Autoimmune CytopeniaAutoimmune Hemolytic Anemia;Pure Red Cell Aplasia;Evans SyndromeDrug: TacrolimusPeking Union Medical College HospitalNULLRecruiting18 Years80 YearsAll80Phase 4China
84NCT03764618
(ClinicalTrials.gov)
April 24, 20193/12/2018A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHAA Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic AnemiaWarm Antibody Autoimmune Hemolytic AnemiaDrug: Fostamatinib disodium;Drug: PlaceboRigel PharmaceuticalsNULLActive, not recruiting18 Years100 YearsAll90Phase 3United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
85NCT04005638
(ClinicalTrials.gov)
February 2, 201917/6/2019Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune CytopeniaBiological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune CytopeniaImmune Thrombocytopenia;Autoimmune Hemolytic Anemia;Autoimmune NeutropeniaBiological: blood sample;Biological: urine sampleUniversity Hospital, BordeauxMinistry for Health and Solidarity, FranceRecruiting18 YearsN/AAll200France
86NCT03538041
(ClinicalTrials.gov)
November 21, 201815/5/2018A Study of INCB050465 in Participants With Autoimmune Hemolytic AnemiaA Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic AnemiaAutoimmune Hemolytic AnemiaDrug: ParsaclisibIncyte CorporationNULLActive, not recruiting18 YearsN/AAll25Phase 2United States;Austria;France;Italy
87EUCTR2017-003652-22-IT
(EUCTR)
18/09/201815/01/2021A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA)A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia - A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA) Autoimmune Hemolytic Anemia (AIHA), immunohemolytic anemia, autoimmune hemolytic anemia, immune complex hemolytic anemia.Warm AIHA, Cold AIHA
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: INCB050465 2.5 mg
Product Code: [INCB050465 2.5 mg]
Product Name: INCB050465 1 mg
Product Code: [INCB050465 1 mg]
INCYTE CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2France;United States;Austria;Italy
88EUCTR2017-003538-10-NL
(EUCTR)
03/09/201818/12/2017Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan
89EUCTR2017-003539-12-NL
(EUCTR)
03/09/201819/12/2017A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusionsA PHASE 3, 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: TNT009
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand
90EUCTR2017-003652-22-AT
(EUCTR)
18/07/201829/03/2018A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA)A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia Autoimmune Hemolytic Anemia (AIHA), immunohemolytic anemia, autoimmune hemolytic anemia, immune complex hemolytic anemia.Warm AIHA, Cold AIHA
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: INCB050465 1 mg
INN or Proposed INN: not yet assigned
Other descriptive name: INCB050465 HYDROCHLORIDE
Product Code: INCB050465 2.5 mg
INN or Proposed INN: not yet assigned
Other descriptive name: INCB050465 HYDROCHLORIDE
Incyte CoorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2France;United States;Austria;Italy
91EUCTR2017-003363-35-IT
(EUCTR)
05/07/201804/11/2020Clinical study to assess the safety, tolerability, efficacy and pharmacokinetics of APL-2 in patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)An open label, prospective, study to assess the safety, tolerability, efficacy and pharmacokinetics of APL-2 in patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD). - Treatment of wAIHA with APL-2 Patients affected by Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
MedDRA version: 20.0;Level: LLT;Classification code 10002045;Term: Anaemia haemolytic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: APL-2
Product Code: APL-2
INN or Proposed INN: APL-2
Product Name: APL-2
Product Code: APL-2
INN or Proposed INN: APL-2
APELLIS PHARMACEUTCIALS, INC.NULLNot RecruitingFemale: yes
Male: yes
12Phase 2United States;Italy
92EUCTR2017-003539-12-IT
(EUCTR)
19/03/201815/01/2021A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of bloodtransfusionsA PHASE 3, 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: TNT009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
BIOVERATIV THERAPEUTICS INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand
93NCT03347422
(ClinicalTrials.gov)
March 17, 201816/11/2017A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood TransfusionA Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood TransfusionCold Agglutinin DiseaseDrug: sutimlimab (BIVV009);Drug: placeboBioverativ, a Sanofi companyNULLCompleted18 YearsN/AAll42Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom
94EUCTR2017-003538-10-IT
(EUCTR)
07/03/201828/01/2021Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLDAGGLUTININ 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: TNT009
INN or Proposed INN: BIVV009
BIOVERATIV THERAPEUTICS INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Norway;Japan;New Zealand
95NCT03347396
(ClinicalTrials.gov)
March 5, 201816/11/2017A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood TransfusionAgglutinin Disease, ColdDrug: SutimlimabBioverativ, a Sanofi companyNULLCompleted18 YearsN/AAll20Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom
96EUCTR2017-003539-12-GB
(EUCTR)
26/02/201823/10/2017A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusionsA PHASE 3, 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: TNT009
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand
97EUCTR2017-003538-10-GB
(EUCTR)
26/02/201823/10/2017Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA PHASE 3, 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: TNT009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ a Sanofi Company Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;New Zealand;Japan
98EUCTR2017-003538-10-DE
(EUCTR)
15/02/201830/10/2017A PHASE 3, 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 A PHASE 3, 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: TNT009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;New Zealand
99EUCTR2017-003539-12-DE
(EUCTR)
15/02/201830/10/2017A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusionsA PHASE 3, 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: TNT009
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand
100EUCTR2017-003539-12-ES
(EUCTR)
06/02/201807/11/2017A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusionsA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Japan;United States;Spain;Austria
101EUCTR2017-003539-12-BE
(EUCTR)
26/01/201806/12/2017A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusionsA PHASE 3, 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: TNT009
Bioverativ USA, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3New Zealand;Japan;Norway;Germany;Netherlands;Australia;Belgium;Canada;France;United Kingdom;Italy;Israel;Austria;Spain;United States
102EUCTR2017-003538-10-BE
(EUCTR)
26/01/201806/12/2017Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA PHASE 3, 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: TNT009
Bioverativ USA Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Norway;Japan;New Zealand
103EUCTR2017-003538-10-ES
(EUCTR)
19/01/201807/11/2017Open-Label with BIVV009 in patients with Cold Agglutinin Disease A PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THE EFFICACY 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.NULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan
104NCT03075878
(ClinicalTrials.gov)
January 10, 20183/3/2017A 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 AnemiaDrug: ALXN1830Alexion PharmaceuticalsNULLTerminated18 YearsN/AAll8Phase 1/Phase 2United States;Jordan
105EUCTR2017-003538-10-NO
(EUCTR)
18/12/201702/11/2017Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA PHASE 3, 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: TNT009
Bioverativ a Sanofi Company Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Norway;Germany;Netherlands;Japan;New Zealand
106EUCTR2017-003538-10-AT
(EUCTR)
15/11/201710/10/2017A PHASE 3, 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 A PHASE 3, 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: TNT009
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Norway;Japan;New Zealand
107EUCTR2017-003539-12-AT
(EUCTR)
15/11/201710/10/2017A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusionsA PHASE 3, 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: TNT009
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand
108NCT03226678
(ClinicalTrials.gov)
August 31, 20177/7/2017Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)An Open Label, Prospective, Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)Warm Autoimmune Hemolytic Anemia;Cold Agglutinin DiseaseDrug: APL-2Apellis Pharmaceuticals, Inc.NULLActive, not recruiting18 YearsN/AAll24Phase 2United States
109NCT02389231
(ClinicalTrials.gov)
May 17, 201713/2/2015Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment Anemil Trial : Phase I/II Clinical Trial Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional TreatmentAutoimmune Hemolytic AnemiaDrug: Interleukine-2University Hospital, BordeauxNULLCompleted18 YearsN/AAll2Phase 1/Phase 2France
110NCT03827603
(ClinicalTrials.gov)
February 21, 201724/1/2019Ibrutinib in Steroid Refractory Autoimmune Hemolytic AnemiaIbrutinib in Steroid Refractory Autoimmune Hemolytic Anemia: ELaboration of Treatment ApproachAIHA - Warm Autoimmune Hemolytic AnemiaDrug: IbrutinibEugene NikitinNULLActive, not recruiting18 YearsN/AAll50Phase 2Russian Federation
111EUCTR2016-002478-11-AT
(EUCTR)
19/07/201601/07/2016Very low doses of Rituximab for autoimmune diseases, for which rituximab is not approved for - a Pilot TrialVery low doses of Rituximab for off-label treatment – a Pilot Trial - Low_Rituximab Autoimmune-haemolytic AnemiaAntiphospholipid SyndromeImmune-mediated Thrombocytopenia
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000154058
MedDRA version: 20.0;Classification code 10023095;Term: ITP;System Organ Class: 100000157088
MedDRA version: 20.0;Level: PT;Classification code 10002817;Term: Antiphospholipid syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Mabthera or biosimilar Rituximab
Product Name: Rituximab
Product Code: Rituximab
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituximab
Medical University of Vienna, Department of Internal medicine INULLNot RecruitingFemale: yes
Male: yes
48Phase 2Austria
112NCT02612558
(ClinicalTrials.gov)
July 201619/11/2015A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic AnemiaWarm Antibody Autoimmune Hemolytic AnemiaDrug: Fostamatinib 150 mg bidRigel PharmaceuticalsNULLCompleted18 YearsN/AAll26Phase 2United States;Canada
113NCT02828670
(ClinicalTrials.gov)
June 7, 201623/6/2016Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)Autoimmune Hemolytic AnemiaBiological: blood sample;Procedure: spleen sampleCentre Hospitalier Universitaire DijonNULLRecruiting18 YearsN/AAll50France
114NCT02502903
(ClinicalTrials.gov)
July 13, 20157/7/2015Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated DisordersSafety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement-mediated Disorders. A Single/Multiple Ascending Dose Phase 1 Study.Bullous Pemphigoid (BP);Cold Agglutinin Disease (CAD);Warm Autoimmune Hemolytic Anemia (WAIHA);End-stage Renal Disease (ESRD)Drug: BIV009;Other: PlaceboBioverativ, a Sanofi companyCelerion Clinical Research GmbH;Assign Data Management and Biostatistics GmbH;ABF Pharmaceutical Services GmbH;Quest Diagnostics-Nichols Insitute;Covance Laboratories - Chantilly;PPD Laboratories - Virginia;Softworld Inc. - Cambridge, MACompleted18 YearsN/AAll122Phase 1Austria
115EUCTR2011-004835-30-FI
(EUCTR)
10/07/201317/06/2013Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy.Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5 Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: Levact
INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Department of Medicine, Haugesund HospitalNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Finland;Denmark;Norway
116NCT02158195
(ClinicalTrials.gov)
July 20135/3/2014Immunopathology of Autoimmune Hemolytic AnemiaImmunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter StudyAutoimmune Hemolytic AnemiaBiological: blood samplesCentre Hospitalier Universitaire DijonNULLUnknown status16 YearsN/AAll24France
117EUCTR2012-003710-13-NL
(EUCTR)
21/03/201321/03/2013C1-inhibitor improves efficacy of red blood cell transfusion in patients suffering from autoimmune hemolytic anemia – an open-labeled pilot trialC1-inhibitor improves efficacy of red blood cell transfusion in patients suffering from autoimmune hemolytic anemia – an open-labeled pilot trial - C1-inhibitor improves efficacy of red blood cell transfusion in patients suffering from autoimmune h AutoImmune Hemolytic Anemia
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: CINRYZE® (C1 esterase inhibitor [human])Academic Medical CenterNULLNot RecruitingFemale: yes
Male: yes
10Phase 2Netherlands
118EUCTR2011-004835-30-DK
(EUCTR)
17/01/201330/11/2012Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy.Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5 Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: Levact
INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Department of Medicine, Haugesund HospitalNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Finland;Denmark;Norway
119NCT02689986
(ClinicalTrials.gov)
January 201316/2/2016Bendamustine and Rituximab Combination Therapy for Cold Agglutinin DiseaseThe CAD5 Study::Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicenter Trial on the Safety and Efficacy of Bendamustine and Rituximab Combination TherapyCold Agglutinin Disease;Autoimmune Hemolytic AnemiaDrug: Bendamustine, RituximabHelse FonnaNULLCompleted18 YearsN/AAll43Phase 2Denmark;Finland;Norway
120NCT01696474
(ClinicalTrials.gov)
December 201227/9/2012Short Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin DiseaseShort Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin DiseaseRefractory Cold Agglutinin DiseaseDrug: BortezomibGruppo Italiano Malattie EMatologiche dell'AdultoNULLCompleted18 YearsN/AAll21Phase 2Italy
121EUCTR2011-004835-30-NO
(EUCTR)
23/10/201229/08/2012Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy.Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5 Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: Levact
INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Department of Medicine, Haugesund HospitalNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Finland;Denmark;Norway
122EUCTR2011-006329-42-IT
(EUCTR)
11/10/201230/10/2012Short treatment with a drug for patients affected by a type of a treatment-resistant anaemia, where the red cells are destroyed by some cold cells (autoantibodies).Short course of Bortezomib in anemic patients with refractory cold agglutinin disease Anaemia with refractory cold agglutinin disease
MedDRA version: 14.1;Level: PT;Classification code 10009868;Term: Cold type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VELCADE*EV 1FL 3,5MG 1MG/MLG.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTONULLNot RecruitingFemale: yes
Male: yes
25Phase 2Italy
123NCT01579110
(ClinicalTrials.gov)
April 201213/4/2012Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.Anemia;Anemia, Hemolytic;Anemia, Hemolytic, Autoimmune;Hemolysis;Hematologic Diseases;Autoimmune Diseases;Immune System Diseases;Pathologic ProcessesDrug: levamisole;Drug: PrednisoneInstitute of Hematology & Blood Diseases HospitalNULLActive, not recruiting18 YearsN/ABoth100Phase 2China
124NCT01181154
(ClinicalTrials.gov)
March 3, 201112/8/2010Rituximab in Auto-Immune Hemolytic AnemiaRituximab in Adult's Warm Auto-Immune Hemolytic Anemia : a Phase III, Double-bind, Randomised Placebo-controlled TrialWarm Autoimmune Hemolytic AnemiaDrug: rituximab (Mabthera®);Drug: PlaceboAssistance Publique - Hôpitaux de ParisHoffmann-La RocheCompleted18 YearsN/AAll32Phase 3France
125NCT01303952
(ClinicalTrials.gov)
January 201124/2/2011Therapy of Chronic Cold Agglutinin Disease With EculizumabTherapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using EculizumabCold Agglutinin DiseaseDrug: EculizumabUniversity Hospital, EssenAlexion PharmaceuticalsCompleted18 YearsN/AAll13Phase 2Germany
126EUCTR2009-016966-97-DE
(EUCTR)
08/06/201008/02/2010Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized, Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients with Cold Agglutinin Disease Using Eculizumab - DECADE TrialTherapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized, Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients with Cold Agglutinin Disease Using Eculizumab - DECADE Trial Cold agglutinin disease
MedDRA version: 12.1;Level: LLT;Classification code 10009868;Term: Cold type haemolytic anaemia
Trade Name: Soliris (R)Universitätsklinikum EssenNULLNot RecruitingFemale: yes
Male: yes
Germany
127NCT00960713
(ClinicalTrials.gov)
June 200916/7/2009The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune DisordersThe RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune DisordersPemphigus;Auto-immune Thrombocytopenic Purpura;Hemolytic Auto-immune Anaemia;Cold Agglutinin Disease;CryoglobulinemiaDrug: Rituximab (MABTHERA® or RITUXAN®).University Hospital, ToulouseNULLCompleted18 YearsN/ABoth35N/AFrance
128EUCTR2007-001377-28-PT
(EUCTR)
09/01/200925/08/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
129NCT01345708
(ClinicalTrials.gov)
January 200928/4/2011A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic AnemiaA Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic AnemiaAutoimmune Hemolytic Disease (Cold Type) (Warm Type)Drug: prednisone, low dose rituximabFondazione OspedaleUniversity Hospital, Udine, ItalyCompleted18 YearsN/ABoth23Phase 2Italy
130EUCTR2008-006713-25-IT
(EUCTR)
23/09/200816/01/2009A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - NDA SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND ANEMIE EMOLITICHE AUTOIMMUNI IDIOPATICHEINN or Proposed INN: RituximabOSPEDALE MAGGIORE DI MILANO (IRCCS)NULLNot RecruitingFemale: yes
Male: yes
Italy
131EUCTR2007-001377-28-DE
(EUCTR)
01/09/200815/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
132EUCTR2007-001377-28-NL
(EUCTR)
15/07/200829/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
133EUCTR2007-001377-28-AT
(EUCTR)
26/06/200827/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
134EUCTR2007-001377-28-FR
(EUCTR)
11/06/200829/02/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
135NCT00392951
(ClinicalTrials.gov)
December 200624/10/2006Sirolimus for Autoimmune Disease of Blood CellsSirolimus for Patients With Chronic and/or Refractory Autoimmune Cytopenias: A Pilot SeriesAutoimmune Pancytopenia;Autoimmune Lymphoproliferative Syndrome (ALPS);Evans Syndrome;Idiopathic Thrombocytopenic Purpura;Anemia, Hemolytic, Autoimmune;Autoimmune Neutropenia;Lupus Erythematosus, Systemic;Inflammatory Bowel Disease;Rheumatoid ArthritisDrug: sirolimusChildren's Hospital of PhiladelphiaNULLCompleted1 Year30 YearsAll30Phase 1/Phase 2United States
136NCT00373594
(ClinicalTrials.gov)
June 20057/9/2006Therapy for Chronic Cold Agglutinin DiseaseTherapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicentre Study on the Safety and Efficacy of Rituximab in Combination With Fludarabine.Cold Agglutinin DiseaseDrug: Rituximab;Drug: FludarabineUniversity of BergenNULLCompleted18 Years90 YearsBoth30Phase 2Norway;Russian Federation
137NCT01134432
(ClinicalTrials.gov)
March 200528/5/2010Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic AnemiaAnti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.Anemia, Hemolytic, AutoimmuneDrug: prednisolone + mabthera;Drug: PrednisoloneCopenhagen University Hospital at HerlevNULLCompleted18 YearsN/ABoth65Phase 3Denmark