Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B

C

Catalyst Biosciences

Status and phase

Terminated
Phase 3

Conditions

Hemophilia B With Inhibitor
Hemophilia A With Inhibitor

Treatments

Biological: MarzAA

Study type

Interventional

Funder types

Industry

Identifiers

NCT04489537
MAA-304

Details and patient eligibility

About

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).

Enrollment

18 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

18 participants in 2 patient groups

MarzAA
Experimental group
Description:
Coagulation Factor VIIa variant, 60 µg/kg by subcutaneous route, administered on-demand during bleeding episodes for a maximum of 3 doses as needed for hemostasis
Treatment:
Biological: MarzAA
Standard of Care
Active Comparator group
Description:
Standard of care administered on-demand during bleeding episodes
Treatment:
Biological: MarzAA

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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