Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04489537 |
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Recruitment Status :
Recruiting
First Posted : July 28, 2020
Last Update Posted : June 10, 2021
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Sponsor:
Catalyst Biosciences
Information provided by (Responsible Party):
Catalyst Biosciences
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Brief Summary:
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hemophilia A With Inhibitor Hemophilia B With Inhibitor | Biological: MarzAA | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 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 |
| Estimated Primary Completion Date : | January 2022 |
| Estimated Study Completion Date : | March 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hemophilia
| Arm | Intervention/treatment |
|---|---|
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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. |
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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. |
Primary Outcome Measures :
- 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 |
Criteria
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
Information from the National Library of Medicine
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
Contacts
| Contact: Howard Levy, MD, PhD, MMM | +1.650.266.8671 | hlevy@catbio.com | |
| Contact: Linda Neuman, MD | +1.650.266.8667 | lneuman@catbio.com |
Locations
Show 43 study locations
Sponsors and Collaborators
Catalyst Biosciences
| 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: | June 10, 2021 |
| Last Verified: | June 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 |
Additional relevant MeSH terms:
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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 |