Last reviewed · How we verify
NCT04489537
Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B
Phase 3 trial testing MarzAA in Hemophilia A With Inhibitor in 18 participants. Terminated before completion.
15 November 2021
Quick facts
| Lead sponsor | Catalyst Biosciences |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 4 May 2021 |
| Primary completion | 15 November 2021 |
| Estimated completion | 1 December 2021 |
| Sites | 43 locations across Georgia, Italy, South Africa, Russia, Malaysia, Ukraine, Taiwan, United Kingdom |
Drugs / interventions tested
- MarzAA — full drug profile →
Conditions studied
- Hemophilia A With Inhibitor — all drugs for Hemophilia A With Inhibitor →
- Hemophilia B With Inhibitor — all drugs for Hemophilia B With Inhibitor →
Sponsor
Catalyst Biosciences — full company profile →
Who can join
12 and older, any sex, with Hemophilia A With Inhibitor or Hemophilia B With Inhibitor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Subcutaneous engineered factor VIIa marzeptacog alfa (activated) in hemophilia with inhibitors: Phase 2 trial of pharmacokinetics, pharmacodynamics, efficacy, and safety.
Mahlangu J, Levy H, Kosinova MV, Khachatryan H, et al · · 2021 · cited 13× · PMID 34430790 · DOI 10.1002/rth2.12576 -
Advances in Development of Drug Treatment for Hemophilia with Inhibitors.
Wichaiyo S. · · 2024 · cited 2× · PMID 39698264 · DOI 10.1021/acsptsci.4c00560 -
The expanding role of protease therapeutics (2012-2026): from replacement therapies to immune system modulation and beyond.
Nelson SE, Martinusen SG, Pho R, Long LF, et al · · 2026 · PMID 42237901 · DOI 10.1042/bcj20260152
Verify or expand the search:
- PubMed search for NCT04489537
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hemophilia A With Inhibitor
Currently open trials in the same condition.
- NCT06312475 — Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors · Phase 3 · active not recruiting
- NCT05888870 — ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor · Phase 4 · recruiting
- NCT04647227 — SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors · Phase 4 · recruiting
Other Catalyst Biosciences trials
Trials by the same sponsor.
- NCT05095623 — A Natural History Study to Assess the Clinical Outcomes of Patients With Complement Factor I Deficiency-Mediated Disease · terminated
- NCT05072912 — Screening Study to Identify Patients With Complement Factor I Deficiencies · terminated
- NCT04548791 — Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders · Phase 1, PHASE2 · terminated
- NCT04072237 — Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia · Phase 1 · completed
- NCT03995784 — Study of Next-Generation Recombinant Factor IX Variant in Adult Subjects With Hemophilia B · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04489537 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Catalyst Biosciences
- Last refreshed: 17 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04489537.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing