Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders
Stopped early · Phase 1/Phase 2
Conditions studied: Factor VII Deficiency, Glanzmann Thrombasthenia, Hemophilia A With Inhibitor
In brief
The purpose of the trial is to evaluate the PK, bioavailability, PD, efficacy and safety of MarzAA for on demand treatment and control of bleeding episodes in adult subjects with inherited bleeding disorders.
Key facts
- Study ID
- NCT04548791
- Run by
- Catalyst Biosciences
- People needed
- 19
- Starts
- 2021-05-17
- Expected to finish
- 2021-12-03
- Last updated by the study team
- 2021-12-21
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of cohort: FVII deficiency, Glanzmann Thrombasthenia, or hemophilia A 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
- Agreement to use highly effective birth control throughout the study if the subject has childbearing potential
You may not qualify if…
- Genotype of FVIID subjects with identified mutations by central lab at screening
- 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, whichever is longer
- Known hypersensitivity to trial or related product
- Known positive antibody to FVII or FVIIa detected by central lab at screening
- Be immunosuppressed
- Significant contraindication to participate
Where it is running
- UC Davis Medical Center — Sacramento, California, United States
- University of California -San Francisco — San Francisco, California, United States
- University of Colorado Hemophilia and Thrombosis Center — Aurora, Colorado, United States
- Rush University — Chicago, Illinois, United States
- Children's Hospital of Michigan — Detroit, Michigan, United States
- Michigan State University Center for Bleeding Disorders & Clotting Disorders — East Lansing, Michigan, United States
- East Carolina University — Greenville, North Carolina, United States
- Mazumdar Shaw Medical Centre — Bengaluru, India
- St. John's Medical College Hospital — Bengaluru, India
- Amrita Institute of Medical Sciences and Research Centre — Kochi, India
- K. J. Somaiya Hospital and Research Centre — Mumbai, India
- Sahyadri Super Speciality Hospital — Pune, India
- Careggi University Hospital — Florence, Italy
- Center for Thrombosis and Haemorrhagic Diseases — Milan, Italy
- Maggiore Polyclinic Hospital, IRCCS Ca' Granda — Milan, Italy
- Children's Hospital BambiNo Gesù, IRCCS (PEDS) — Roma, Italy
- City of Health and Science of Turin — Turin, Italy
- Territorial Clinical Hospital — Barnaul, Russia
- National Medical Hematology Research Center under the Ministry of Healthcare of the Russian Federation — Moscow, Russia
- Institute of Blood Pathology and Transfusion Medicine, Department of Surgery and Clinical Transfusiology — Lviv, Ukraine
Full record on ClinicalTrials.gov
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