BIVV009 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 61 | 自己免疫性溶血性貧血 | 20 |
61. 自己免疫性溶血性貧血
臨床試験数 : 146 / 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2031210392 | 07/12/2021 | 27/10/2021 | Sutimlimab (BIVV009) for the adult participants with cold agglutinin disease (CAD) who have completed Phase 3 studies (CARDINAL or CADENZA) in Japan | An 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 Disease | Drug: sutimlimab (BIVV009) Pharmaceutical Form: solution for injection, Route of Administration: intravenous(iv) | Tanaka Tomoyuki | NULL | Not Recruiting | >= 20age old | Not applicable | Both | 7 | Phase 3 | Japan |
| 2 | NCT05132127 (ClinicalTrials.gov) | November 11, 2021 | 11/11/2021 | Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan | An 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 Disease | Drug: sutimlimab | Sanofi | NULL | Completed | 20 Years | N/A | All | 7 | Phase 3 | Japan |
| 3 | EUCTR2017-003538-10-NL (EUCTR) | 03/09/2018 | 18/12/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR | Bioverativ USA, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan | ||
| 4 | EUCTR2017-003539-12-NL (EUCTR) | 03/09/2018 | 19/12/2017 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand | ||
| 5 | EUCTR2017-003539-12-IT (EUCTR) | 19/03/2018 | 15/01/2021 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of bloodtransfusions | A 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 INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand | ||
| 6 | NCT03347422 (ClinicalTrials.gov) | March 17, 2018 | 16/11/2017 | A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion | A 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 Transfusion | Cold Agglutinin Disease | Drug: sutimlimab (BIVV009);Drug: placebo | Bioverativ, a Sanofi company | NULL | Completed | 18 Years | N/A | All | 42 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom |
| 7 | EUCTR2017-003538-10-IT (EUCTR) | 07/03/2018 | 28/01/2021 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A 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 INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Norway;Japan;New Zealand | ||
| 8 | NCT03347396 (ClinicalTrials.gov) | March 5, 2018 | 16/11/2017 | A 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 Transfusion | Agglutinin Disease, Cold | Drug: Sutimlimab | Bioverativ, a Sanofi company | NULL | Completed | 18 Years | N/A | All | 20 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom |
| 9 | EUCTR2017-003538-10-GB (EUCTR) | 26/02/2018 | 23/10/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | 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 a Sanofi Company Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;New Zealand;Japan | ||
| 10 | EUCTR2017-003539-12-GB (EUCTR) | 26/02/2018 | 23/10/2017 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand | ||
| 11 | EUCTR2017-003539-12-DE (EUCTR) | 15/02/2018 | 30/10/2017 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand | ||
| 12 | EUCTR2017-003538-10-DE (EUCTR) | 15/02/2018 | 30/10/2017 | 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 | 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. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;New Zealand | ||
| 13 | EUCTR2017-003539-12-ES (EUCTR) | 06/02/2018 | 07/11/2017 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza | Primary Cold Agglutinin Disease MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIVV009 Product Code: BIVV009 INN or Proposed INN: BIVV009 Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR | Bioverativ USA Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Japan;United States;Spain;Austria | ||
| 14 | EUCTR2017-003539-12-BE (EUCTR) | 26/01/2018 | 06/12/2017 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;Italy;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand | ||
| 15 | EUCTR2017-003538-10-BE (EUCTR) | 26/01/2018 | 06/12/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | 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 | Bioverativ USA Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Norway;Japan;New Zealand | ||
| 16 | EUCTR2017-003538-10-ES (EUCTR) | 19/01/2018 | 07/11/2017 | Open-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. | NULL | Not 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): no | United States;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan | ||
| 17 | EUCTR2017-003538-10-NO (EUCTR) | 18/12/2017 | 02/11/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | 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 | Bioverativ a Sanofi Company Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Norway;Germany;Netherlands;Japan;New Zealand | ||
| 18 | EUCTR2017-003539-12-AT (EUCTR) | 15/11/2017 | 10/10/2017 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand | ||
| 19 | EUCTR2017-003538-10-AT (EUCTR) | 15/11/2017 | 10/10/2017 | 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 | 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. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Norway;Japan;New Zealand | ||
| 20 | NCT02502903 (ClinicalTrials.gov) | July 13, 2015 | 7/7/2015 | Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders | Safety, 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: Placebo | Bioverativ, a Sanofi company | Celerion 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, MA | Completed | 18 Years | N/A | All | 122 | Phase 1 | Austria |