Phase I, randomized, double-blind, placebo-controlled, single-dose escalation study of the recombinant factor VIIa variant BAY 86-6150 in hemophilia

Journal of Thrombosis and Haemostasis

Volumn 10, Issue 5, 2012, Pages 773-780

  Mahlangu, J N ^a   Coetzee, M J ^b   Laffan, M ^c   Windyga, J ^d   Yee, T T ^e   Schroeder, J ^f   Haaning, J ^g   Siegel, J E ^h   Lemm, G ^f  

^a UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^b UNIVERSITY OF THE FREE STATE   (South Africa)

^c HAMMERSMITH HOSPITAL   (United Kingdom)

^d INSTITUTE OF HEMATOLOGY AND TRANSFUSION MEDICINE   (Poland)

^e ROYAL FREE HOSPITAL   (United Kingdom)

^f BAYER PHARMA AG   (Germany)

^g Present at Bayer HealthCare Pharmaceuticals   (United States)

^h BAYER CORPORATION   (United States)

Author keywords

Hemophilia; Inhibitors; Pharmacokinetics pharmacodynamics; Recombinant factor VIIa variant; Safety; Tolerability

Indexed keywords

BAY 866150; NEUTRALIZING ANTIBODY; PLACEBO; RECOMBINANT BLOOD CLOTTING FACTOR 7A; THROMBIN; UNCLASSIFIED DRUG; BAY 86 6150; BAY 86-6150; BLOOD CLOTTING FACTOR 7A; COAGULATING AGENT; RECOMBINANT FVIIA; RECOMBINANT PROTEIN;

ADULT; ARTICLE; BLEEDING; CLINICAL ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FEVER; FLU LIKE SYNDROME; FOLLOW UP; HEADACHE; HEMOPHILIA A; HEMOPHILIA B; HUMAN; IMMUNOGENICITY; MALE; MULTICENTER STUDY; MYALGIA; PARTIAL THROMBOPLASTIN TIME; PERIPHERAL EDEMA; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; THROMBIN TIME; UPPER RESPIRATORY TRACT INFECTION; ADOLESCENT; AGED; BLOOD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DOSE RESPONSE; DRUG MONITORING; EUROPE; HALF LIFE TIME; IMMUNOLOGY; METABOLISM; METHODOLOGY; MIDDLE AGED; SOUTH AFRICA; TREATMENT OUTCOME;

ADOLESCENT; ADULT; AGED; ANTIBODIES, NEUTRALIZING; COAGULANTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG MONITORING; EUROPE; FACTOR VIIA; HALF-LIFE; HEMOPHILIA A; HEMOPHILIA B; HUMANS; MALE; MIDDLE AGED; PARTIAL THROMBOPLASTIN TIME; PLACEBOS; PROTHROMBIN TIME; RECOMBINANT PROTEINS; SOUTH AFRICA; THROMBIN; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84860457217     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/j.1538-7836.2012.04667.x     Document Type: Article

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