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Coagulation Factor

Coagulation Factor VIIa variant for Hemophilia A

Phase 1 & 2
Waitlist Available
Research Sponsored by Catalyst Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dosing period for each stage in a cohort will be approximately 5 to 11 days
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Hemophilia A
  • Glanzmann's Thrombasthenia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dosing period for each stage in a cohort will be approximately 5 to 11 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and dosing period for each stage in a cohort will be approximately 5 to 11 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bleeding episode treatment success
Comparative MarzAA activity by dose level/stage and confirm the Phase 2 dose

Side effects data

From 2019 Phase 2 trial • 11 Patients • NCT03407651
20%
Anaemia
10%
Haematoma
10%
Respiratory tract infection
10%
Arthralgia
10%
Contusion
10%
Injection site reaction
10%
Hypertension
10%
Panic attack
10%
Haemorrhagic stroke
10%
Haemarthrosis
10%
Haemorrhagic vasculitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
MarzAA 30 ug/kg
MarzAA SC 30 μg/kg
MarzAA 60 ug/kg
MarzAA IV 18 μg/kg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
For Phase 1, a Coagulation Factor VIIa variant by intravenous route, 18 μg/kg, followed by ascending doses by subcutaneous route, 30 μg/kg, 45 μg/kg, 60 μg/kg, 120 μg/kg, and 180 μg/kg, for PK and PD assessment. For Phase 2, Coagulation Factor VIIa, 60 μg/kg by subcutaneous route, administered on demand during bleeding episodes for a maximum of 3 doses as needed for hemostasis.
Group II: Cohort 2Experimental Treatment1 Intervention
For Phase 1, a Coagulation Factor VIIa variant by intravenous route, 18 μg/kg, followed by ascending doses by subcutaneous route, 30 μg/kg, 45 μg/kg, 60 μg/kg, 120 μg/kg, and 180 μg/kg, for PK and PD assessment. For Phase 2, Coagulation Factor VIIa, 60 μg/kg by subcutaneous route, administered on demand during bleeding episodes for a maximum of 3 doses as needed for hemostasis.
Group III: Cohort 1Experimental Treatment1 Intervention
For Phase 1, a Coagulation Factor VIIa variant by intravenous route, 18 μg/kg, followed by ascending doses by subcutaneous route, 10 μg/kg, 20 μg/kg, 30 μg/kg, 40 μg/kg, and 60 μg/kg, for PK and PD assessment. For Phase 2, Coagulation Factor VIIa, 20 μg/kg by subcutaneous route, administered on demand during bleeding episodes for a maximum of 3 doses as needed for hemostasis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coagulation Factor VIIa variant
2017
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Catalyst BiosciencesLead Sponsor
8 Previous Clinical Trials
202 Total Patients Enrolled
6 Trials studying Hemophilia A
86 Patients Enrolled for Hemophilia A
~4 spots leftby Oct 2025
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