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Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia

NCT04072237 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-09-13

Study results available
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Summary

This multi-center, open label Phase 1 study will evaluate the pharmacokinetics, pharmacodynamics, and safety of a single IV dose of MarzAA followed by ascending single SC doses of MarzAA in adult subjects with moderate or severe Hemophilia A or B, with or without an inhibitor.

Conditions

  • Hemophilia A
  • Hemophilia B
  • Hemophilia A With Inhibitor
  • Hemophilia B With Inhibitor
  • Hemophilia A Without Inhibitor
  • Hemophilia B Without Inhibitor

Interventions

BIOLOGICAL

MarzAA (marzeptacog alfa [activated])

Single intravenous dose and ascending doses of subcutaneous injection of MarzAA (Coagulation Faction VIIa Variant)

Sponsors & Collaborators

  • Catalyst Biosciences

    lead INDUSTRY

Principal Investigators

  • Howard Levy, MD, PhD, MMM · Sponsor GmbH

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2020-04-30
Completion
2020-06-17
FDA Drug
Yes

Countries

  • Bulgaria
  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04072237 on ClinicalTrials.gov