Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B
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ClinicalTrials.gov Identifier: NCT04489537 |
Recruitment Status :
Terminated
(Sponsor decision (not a safety decision))
First Posted : July 28, 2020
Last Update Posted : December 17, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemophilia A With Inhibitor Hemophilia B With Inhibitor | Biological: MarzAA | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous Marzeptacog Alfa (Activated) For On Demand Treatment and Control of Bleeding Episodes in Subjects With Hemophilia A or Hemophilia B, With Inhibitors: The Crimson 1 Study |
Actual Study Start Date : | May 4, 2021 |
Actual Primary Completion Date : | November 15, 2021 |
Actual Study Completion Date : | December 1, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: MarzAA
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
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Biological: MarzAA
A cross over design to assess the efficacy of a dosing regimen of 60 µg/kg of MarzAA compared with standard of care for the treatment of bleeding episodes. |
Active Comparator: Standard of Care
Standard of care administered on-demand during bleeding episodes
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Biological: MarzAA
A cross over design to assess the efficacy of a dosing regimen of 60 µg/kg of MarzAA compared with standard of care for the treatment of bleeding episodes. |
- Bleeding episode treatment success [ Time Frame: 24 hours after the first administration of study drug ]Proportion of bleeding events treated with MarzAA achieving hemostatic efficacy based on a four-point scale according to the Investigator's assessment compared with standard of care.

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489537

Responsible Party: | Catalyst Biosciences |
ClinicalTrials.gov Identifier: | NCT04489537 |
Other Study ID Numbers: |
MAA-304 |
First Posted: | July 28, 2020 Key Record Dates |
Last Update Posted: | December 17, 2021 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hemophilia A Hemophilia B Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Genetic Diseases, X-Linked |