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Haemocomplettan® P
Haemocomplettan® P is a prothrombin complex concentrate (PCC) that replaces deficient vitamin K-dependent clotting factors to restore coagulation capacity.
Haemocomplettan® P is a prothrombin complex concentrate (PCC) that replaces deficient vitamin K-dependent clotting factors to restore coagulation capacity. Used for Reversal of vitamin K antagonist (warfarin) anticoagulation in acute bleeding or urgent procedures, Treatment of coagulopathy due to liver disease or factor deficiency.
At a glance
| Generic name | Haemocomplettan® P |
|---|---|
| Also known as | RiaSTAP, Fibrinogen concentrate |
| Sponsor | CSL Behring |
| Drug class | Prothrombin complex concentrate (PCC) |
| Target | Clotting factors II, VII, IX, X |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
This product contains concentrated human clotting factors II, VII, IX, and X (vitamin K-dependent factors) derived from human plasma. It is used to rapidly correct coagulopathy and restore hemostasis in patients with deficiency of these factors due to vitamin K antagonist therapy, liver disease, or other causes of factor deficiency.
Approved indications
- Reversal of vitamin K antagonist (warfarin) anticoagulation in acute bleeding or urgent procedures
- Treatment of coagulopathy due to liver disease or factor deficiency
Common side effects
- Thromboembolism (venous thromboembolism, myocardial infarction, stroke)
- Headache
- Nausea
- Fever
- Hypersensitivity reactions
Key clinical trials
- Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap (PHASE2)
- An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency
- Strategy of Transfusion in Trauma Patients - STATA Trial (PHASE4)
- Human Fibrinogen - Pharmacokinetics (PHASE2)
- Haemocomplettan® P During Elective Complex Cardiac Surgery (PHASE2, PHASE3)
- Haemocomplettan® P During Aortic Replacement (PHASE2)
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:
- Haemocomplettan® P CI brief — competitive landscape report
- Haemocomplettan® P updates RSS · CI watch RSS
- CSL Behring portfolio CI