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aPCC
aPCC is an anticoagulant that works by replacing and controlling the activity of natural anticoagulant proteins in the blood.
aPCC is an anticoagulant that works by replacing and controlling the activity of natural anticoagulant proteins in the blood. Used for Reversal of anticoagulation due to warfarin or other vitamin K antagonists in patients with acute major bleeding or at high risk of bleeding, Prophylaxis of bleeding in patients with hemophilia A or B undergoing surgery.
At a glance
| Generic name | aPCC |
|---|---|
| Also known as | Factor Eight Inhibitor Bypassing Activity (FEIBA®) |
| Sponsor | Hoffmann-La Roche |
| Drug class | Prothrombin complex concentrate |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
aPCC is a prothrombin complex concentrate that contains all four vitamin K-dependent clotting factors (II, VII, IX, and X). It is used to reverse the anticoagulant effects of warfarin and other vitamin K antagonists in patients with acute bleeding or at high risk of bleeding.
Approved indications
- Reversal of anticoagulation due to warfarin or other vitamin K antagonists in patients with acute major bleeding or at high risk of bleeding
- Prophylaxis of bleeding in patients with hemophilia A or B undergoing surgery
Common side effects
- Hypersensitivity reactions
- Thromboembolic events
- Anaphylaxis
Key clinical trials
- HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients (PHASE3)
- Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage
- A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) in Pediatric, Adolescent and Adult Participants With Hemophilia B (PHASE1, PHASE2)
- Open-Label Single Ascending Dose of Adeno-associated Virus Serotype 8 Factor IX Gene Therapy in Adults With Hemophilia B (PHASE1, PHASE2)
- A Trial That Evaluates Disease Characteristics in Hemophilia B Adult Male Participants Receiving Prophylaxis With Standard of Care Factor IX Protein (FIX) Replacement Therapy
- Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B (PHASE2)
- An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
- Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- aPCC CI brief — competitive landscape report
- aPCC updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI