A Study to Assess the Efficacy and Safety of BIVV009 in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03347396|
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : April 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Agglutinin Disease, Cold||Drug: BIVV009||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||November 20, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2020|
Participants will receive an intravenous (IV) infusion of BIVV009. Participants who complete Part A per protocol through the end of treatment visit (Day 182) will participate in Part B, and continue to receive BIVV009 up to 1 year after last patient out (LPO) in Part A.
BIVV009 will be administered as IV infusion.
- Part A: Percentage of Participants With Response (R) [ Time Frame: Up to Week 26 ]A participant who meets all of the following criteria will be considered a responder: who did not receive a blood transfusion from Week 5 through Week 26 (end of treatment) and did not receive treatment for cold agglutinin disease (CAgD) beyond what is permitted per protocol. Additionally the participant's hemoglobin (Hgb) level must meet either of the following criteria: Hgb level greater than or equal to (>=) 12 gram per deciliter (g/dL) at the treatment assessment endpoint, or Hgb increased >= 2 g/dL from baseline (defined as the last Hgb value before administration of the first dose of study drug) at treatment assessment endpoint.
- Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Approximately 1 year ]An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
- Part A: Mean Change From Baseline in Bilirubin up to Week 26 [ Time Frame: Baseline up to Week 26 ]Mean change from baseline in bilirubin up to Week 26 will be assessed.
- Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) [ Time Frame: Baseline up to Week 26 ]FACIT-Fatigue scale consists of 13 questions assessed using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question are added to obtain a total score. The range of possible scores is 0-52, with higher score indicating more fatigue.
- Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) up to Week 26 [ Time Frame: Baseline up to Week 26 ]Mean change from baseline in LDH up to Week 26 will be assessed.
- Part A: Number of Blood Transfusions After the First 5 Weeks of Study Drug Administration [ Time Frame: 5 Weeks ]Number of transfusions after the first 5 weeks of study drug administration will be assessed.
- Part A: Number of Blood Units Transfused After the First 5 Weeks of Study Drug Administration [ Time Frame: 5 Weeks ]Number of blood units transfused after the first 5 weeks of study drug administration will be assessed.
- Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level up to Week 26 [ Time Frame: Baseline up to Week 26 ]Mean change from baseline in Hgb level up to Week 26 will be assessed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347396
|Contact: Bioverativ Therapeutics Inc, Waltham, MA, USA||1-844-308-0808(US only)||email@example.com|
|United States, California|
|The Oncology Institute of Hope and Innovation||Recruiting|
|Whittier, California, United States, 90603|
|Contact: Kirsten Bettino, Study Coordinator 1 562-693-4477 firstname.lastname@example.org|
|Principal Investigator: Dr. Richy Agajanian|
|United States, District of Columbia|
|Georgetown University Medical Center||Recruiting|
|Georgetown, District of Columbia, United States, 20007|
|Contact: Bradford Simmons, Study Coordinator 1 202-687-0116 email@example.com|
|Principal Investigator: Dr. Catherine Broome|
|United States, New York|
|Montefiore Medical Center||Recruiting|
|New York, New York, United States, 10461|
|Contact: Kelsey Branch, Study Coordinator 718-430-2748 firstname.lastname@example.org|
|Contact: Elena Crouch, Study Coordinator email@example.com|
|Principal Investigator: Dr. Irina Murakhovskaya|
|New York Medical College at Westchester Medical Center||Recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Saleha Batool 914-493-3045 Saleha_Batool@nymc.edu|
|Principal Investigator: Robert G. Lerner, MD|
|Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Centre Hospitalier Jolimont||Recruiting|
|La Louvière, Belgium, 7100|
|University Hospitals Leuven||Recruiting|
|Leuven, Belgium, 3000|
|University of Alberta||Recruiting|
|Edmonton, Canada, T6G1Z1|
|CHU de Caen||Recruiting|
|Caen, France, 14033|
|Centre Hospitalier Henri Mondor||Recruiting|
|Créteil, France, 94000|
|Centre Hospitalier Lyon Sud||Recruiting|
|Lyon, France, 69495|
|Dresden, Germany, 1307|
|Essen, Germany, 45147|
|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico||Recruiting|
|Milan, Italy, 20122|
|Haukeland University Hospital||Recruiting|
|Bergen, Norway, 5053|
|St Olavs Hospital, Avdeling for blodsykdommer||Recruiting|
|Trondheim, Norway, 7030|
|Hospital Universitario Puerta de Hierro||Recruiting|
|Majadahonda, Madrid, Spain, 28222|
|Hospital Universitario Virgen del Rocio||Recruiting|
|Sevilla, Spain, 41013|
|Hospital Universitario Dr. Peset||Recruiting|
|Valencia, Spain, 46017|