anti-inhibitor coagulant complex (activated prothrombin complex concentrate)

Trade name: Autoplex-T

Biologicalapproved

Approved

Dec 21, 1979

Clinical trial activity

15 trials · 15 clinical orgs · 1 marketing orgs

Phase 1
1
Phase 2
8
Phase 3
7
Phase 4
4

Earliest trial started Jul 1, 2000 (NCT00166309)

Timeline

1970s

  1. Dec 21, 1979

    Takeda — Earliest FDA Approval

  2. Dec 21, 1979

    Takeda — NDA Secondary Org

  3. Dec 21, 1979

    Takeda — NDA Organization

2000s

  1. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2009

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2016

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedDec 21, 1979

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • activated prothrombin complex
  • aicc complex
  • anti-inhibitor coagulant complex
  • anti-inhibitor coagulant complex
  • anti-inhibitor coagulant complex
  • antiinhibitor coagulant complex
  • antiinhibitor coagulant complex
  • anti-inhibitory coagulant complex
  • apcc
  • autoplex
  • factor eight inhibitor bypassing activity
  • factor viii bypassing fraction
  • factor viii inhibitor bypassing activity
  • factor viii inhibitor bypassing activity
  • factor viii inhibitor bypassing fraction
  • factor viii inhibitor bypassing fraction
  • feiba
  • feiba
  • feiba-vh
  • prothrombin complex, activated

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07032792Phase 2Jun 30, 2025Northwell Health
NCT05156983Phase 3Mar 21, 2022Takeda
NCT04563520Phase 3Dec 31, 2021Emory University, Takeda
NCT05020483Phase 2Oct 28, 2021Mayo Clinic
NCT04867837Phase 3Sep 1, 2021Octapharma
NCT04205175Phase 4Feb 29, 2020Children's Hospital Los Angeles, Takeda
NCT03417102Phase 3Mar 22, 2018Genzyme, Sanofi
NCT02764489Phase 3Jan 1, 2017Baxalta
NCT02577614Phase 1Feb 1, 2016Oregon Health and Science University
NCT01800435Phase 4Oct 1, 2011Osaka University
NCT00851721Phase 3Mar 1, 2009Baxalta
NCT00284193Phase 4Jan 1, 2005Tel Aviv University
NCT00221195Phase 2/Phase 3 (Phase 3)Jun 1, 2003Tulane University
NCT00108797Phase 4Sep 1, 2001Novo Nordisk
NCT00166309N/AJul 1, 2000Lund University
Showing 15 of 15 trials
Page 1 / 1

Organizations

Research & Development (15)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
TakedaFor profit3122020
BaxaltaFor profit2212009
Children's Hospital Los AngelesAcademic/Hospital1112020
Emory UniversityAcademic/Hospital1112021
GenzymeFor profit1112018
Lund UniversityAcademic/Hospital1112000
Mayo ClinicAcademic/Hospital1112021
Northwell HealthAcademic/Hospital1112025
Novo NordiskFor profit1112001
OctapharmaFor profit1112021
Oregon Health and Science UniversityAcademic/Hospital1112016
Osaka UniversityAcademic/Hospital1112011
SanofiFor profit1012018
Tel Aviv UniversityAcademic/Hospital1112005
Tulane UniversityAcademic/Hospital1112003
15 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
TakedaFor profitNDA2Dec 21, 1979
TakedaFor profitNDADec 21, 1979