Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B
Stopped early · Phase 3
Conditions studied: Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
In brief
The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their standard of care (SOC).
Key facts
- Study ID
- NCT04489537
- Run by
- Catalyst Biosciences
- People needed
- 18
- Starts
- 2021-05-04
- Expected to finish
- 2021-12-01
- Last updated by the study team
- 2021-12-17
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of congenital hemophilia A or B with inhibitors
- Male or Female, age 12 or older
- History of frequent bleeding episodes
- Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 before any study related activities
You may not qualify if…
- Previous participation in a clinical trial evaluating a modified rFVIIa agent
- Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect
- Known hypersensitivity to trial or related product
- Known positive antibody to FVII or FVIIa detected by central lab at screening
- Have a coagulation disorder other than hemophilia A or B
- Be immunosuppressed
- Significant contraindication to participate
Where it is running
- Phoenix Children's Hospital — Phoenix, Arizona, United States
- Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
- Hematology Center after Prof. R. Yeolyan — Yerevan, Armenia
- JSC "K.Eristavi National Center of Experimental and Clinical Surgery" — Tbilisi, Georgia
- Magyar Honvédség Egészségügyi Központ, Országos Haemophilia Központ — Budapest, Hungary
- Nirmal Hospital — Gujrāt, India
- K.L.E.S Dr. Prabhakar Kore Hospital and Medical Research Centre — Kārnād, India
- Sanjay Gandhi Postgraduate Institute of Medical Sciences — Lucknow, India
- K.J Somaiya Hospital and Research Centre — Mumbai, India
- MCGM - Comprehensive Thalassemia Care, Pediatric Hematology-Oncology & BMT Centre — Mumbai, India
- Sahyadri Specialty Hospital — Mumbai, India
- Grant Medical Foundation, Ruby Hall Clinic — Pune, India
- All India Institute of Medical Sciences, Rishikesh — Rishikesh, India
- Azienda Ospedaliero-Universitaria Careggi — Florence, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano — Milan, Italy
- Azienda Ospedaliera Universitaria Federico II — Naples, Italy
- Citta della Salute e della Scienza di Torino - Ospedale le Molinette — Torino, Italy
- Hospital Ampang — Ampang, Malaysia
- Raja Perempuan Zainab II Hospital — Kota Bharu, Malaysia
- Queen Elizabeth Hospital Malaysia — Kota Kinabalu, Malaysia
- Hospital Tunku Azizah Kuala Lumpur — Kuala Lumpur, Malaysia
- Tuanku Ja'afar Hospital, Seremban — Sungai Petani, Malaysia
- Instituto de Investigaciones Aplicada a la Neurociencia A.C. — Durango, Mexico
- Instituto Nacional de Pediatria — Mexico City, Mexico
- Investigación e Innovación en Medicina Traslacional S.A.P.I. de C.V. — Mexico City, Mexico
Full record on ClinicalTrials.gov
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