A phase II open-label study evaluating hemostatic activity, pharmacokinetics and safety of recombinant porcine factor VIII (OBI-1) in hemophilia A patients with alloantibody inhibitors directed against human FVIII

被引:14
|
作者
Mahlangu, Johnny [1 ]
Andreeva, Tatiana A. [2 ]
Macfarlane, Donald [3 ]
Reding, Mark T. [4 ]
Walsh, Christopher [5 ]
Ritchie, Bruce [6 ]
Ewing, Nadia [7 ]
Kessler, Craig M. [8 ]
Kempton, Christine [9 ]
Libby, Edward [10 ]
Zozulya, Nadezda [11 ]
Shapiro, Amy D. [12 ]
St-Louis, Jean [13 ]
Warrier, Indira [14 ]
Hoots, W. Keith [15 ]
Gruppo, Ralph A. [16 ]
Mueksch, Josef N. [17 ]
机构
[1] Johannesburg Hosp, Parktown, South Africa
[2] St Petersburg State Med Inst, St Petersburg, Russia
[3] Univ Iowa Hosp & Clin, Iowa City, IA 52242 USA
[4] Univ Minnesota Hosp, Minneapolis, MN USA
[5] Mt Sinai Sch Med, New York, NY USA
[6] Univ Alberta, Edmonton, AB, Canada
[7] City Hope Natl Med Ctr, Duarte, CA USA
[8] Georgetown Univ, Med Ctr, Washington, DC USA
[9] Emory Childrens Ctr, Atlanta, GA USA
[10] Univ New Mexico, Albuquerque, NM 87131 USA
[11] Russian Acad Med Sci, Hematol Res Ctr, Moscow, Russia
[12] Indiana Univ, Hemophilia & Thrombosis Ctr Indiana, Indianapolis, IN USA
[13] Hop Maison Neuve Rosemont, Montreal, PQ, Canada
[14] Childrens Hosp Michigan, Detroit, MI 48201 USA
[15] Gulf States Hemophilia & Thrombophelia Ctr, Houston, TX USA
[16] Cincinnati Childrens Hosp, Cincinnati, OH USA
[17] Octagen Corp, Blue Bell, PA USA
关键词
D O I
10.1182/blood.V110.11.783.783
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
783
引用
收藏
页码:241A / 241A
页数:1
相关论文
共 50 条
  • [31] The safety, tolerability, and pharmacokinetics of BAT8001 in patients with human epidermal growth factor receptor-2 (HER2)-positive metastatic breast cancer: An open-label, dose-up, phase 1 study
    Wang, Shusen
    Hong, Ruoxi
    Wang, Liye
    Xu, Fei
    Xia, Wen
    CANCER RESEARCH, 2020, 80 (04)
  • [32] Phase 1b open-label study evaluating the safety, pharmacokinetics, and preliminary efficacy of ABT-165 plus FOLFIRI in patients with second-line (2L) colorectal cancer (CRC)
    Wainberg, Z.
    Strickler, J.
    Gordon, M.
    Barve, M.
    Wang, L.
    Yue, H.
    Motwani, M.
    Kasichayanula, S.
    Naumovski, L.
    Hamilton, E.
    ANNALS OF ONCOLOGY, 2018, 29 : 66 - 66
  • [33] A Phase 1/2a, multicenter, open-label, non-randomized first-in-human study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1303 in patients with advanced/metastatic solid tumors
    Hamilton, Erika
    Zhang, Jian
    Liu, Liming
    Gao, Jie
    Shi, Rong
    Liu, Shengxue
    Wei, Gu
    Qiu, Yang
    Moore, Kathleen
    CANCER RESEARCH, 2023, 83 (08)
  • [34] Achievement of Normal Circulating Factor VIII Activity Following Bmn 270 AAV5-FVIII Gene Transfer: Interim, Long-Term Efficacy and Safety Results from a Phase 1/2 Study in Patients with Severe Hemophilia a
    Pasi, K. John
    Rangarajan, Savita
    Kim, Benjamin
    Lester, Will
    Perry, David
    Madan, Bella
    Tavakkoli, Fatemeh
    Yang, Ke
    Pierce, Glenn F.
    Wong, Wing Yen
    BLOOD, 2017, 130
  • [35] An open-label, multicenter phase 1 study to characterize safety, tolerability, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics of VIP943 monotherapy in patients with advanced CD123+hematologic malignancies.
    Strickland, Stephen Anthony
    Curran, Emily K.
    Jamy, Omer Hassan
    Percival, Mary-Elizabeth
    Johnson, Amy J.
    Birkett, Joseph
    Huang, Xin
    Frigault, Melanie M.
    Lerchen, Hans-Georg
    Stelte-Ludwig, Beatrix
    Navarro, Tasheda
    Peck, Jim
    Gross, Wyatt
    Izumi, Raquel
    Hamdy, Ahmed M.
    Daver, Naval Guastad
    JOURNAL OF CLINICAL ONCOLOGY, 2024, 42 (16)
  • [36] A first-in-human, phase 1a/1b, open-label, dose-escalation and expansion study to investigate the safety, pharmacokinetics, and antitumor activity of the RAF dimer inhibitor BGB-3245 in patients with advanced or refractory tumors
    Schram, Alison M.
    Subbiah, Vivek
    Sullivan, Ryan
    Cosman, Rasha
    Liu, Jia
    Sbar, Eric I.
    Thuy Hoang
    Chen, Jiarong
    Johnson, Mark
    Amoruccio, Vincent
    Shearer, Todd
    Kamal, Adeela
    Lewis, Jocelyn
    Shao, Wenlin
    Edris, Badreddin
    Luo, Lusong
    Desai, Jayesh
    CANCER RESEARCH, 2023, 83 (08)
  • [37] A phase II open-label clinical study of efficacy and safety of recombinant human N-acetylgalactosamine 4-sulfatase (rhASB) enzyme replacement therapy in patients with mucopolysaccharidosis VI (Maroteaux-Lamy syndrome).
    Harmatz, P
    Ketteridge, D
    Steiner, R
    Simon, J
    Waterson, J
    Oates, S
    Giugliani, R
    Schwartz, I
    Guffon, N
    Miranda, CS
    Keppen, L
    Teles, EL
    Hopwood, J
    AMERICAN JOURNAL OF HUMAN GENETICS, 2003, 73 (05) : 623 - 623
  • [38] An open-label, MRCT phase I/II study evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of first-in-class bi-ligand-drug conjugate CBP-1019 in patients (pts) with advanced solid tumors
    Liu, D.
    Shen, L.
    Sun, Y.
    Li, N.
    Marathe, O.
    Huang, R.
    Shao, J.
    Xu, M.
    Pan, B.
    Pan, F.
    Gao, S.
    Gong, J.
    ANNALS OF ONCOLOGY, 2024, 35 : S512 - S513
  • [39] Trial in Progress: The Phase III, Randomized, Open-Label, Multicenter COMMODORE 1 Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with Complement Inhibitors
    Risitano, Antonio
    Roth, Alexander
    Kulasekararaj, Austin
    Pu, Jeffrey
    Nishimura, Jun-Ichi
    Wright, Lilyan
    Appius, Anita
    Sostelly, Alexandre
    Sreckovic, Sasha
    Vignal, Charlotte
    Munir, Talha
    BLOOD, 2020, 136
  • [40] A phase Ib/II, open-label, multicenter study to evaluate the safety, efficacy, and pharmacokinetics/pharmacodynamics of avb3/5 integrin and neuropilin-1 targeting peptide LSTA1 in patients with metastatic pancreatic ductal adenocarcinoma
    Xu, Jianming
    Niu, Zuoxing
    Bai, Yuxian
    Qiu, Wensheng
    Cui, Jiuwei
    Qu, Xiujuan
    Wu, Zheng
    Zha, Yong
    Zhang, Tao
    Cheng, Wei
    Han, Cuicui
    Si, Meimei
    Li, Lingyan
    Kang, Xiaoyan
    JOURNAL OF CLINICAL ONCOLOGY, 2023, 41 (16)