On-demand Trial Results: Efficacy

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Methods

COAGADEX was studied in a prospective, open-label, multicenter, non-randomized phase III study in 16 patients with severe/moderate factor X deficiency (Study Ten 01)1,2

  • COAGADEX was administered on demand or for short-term prophylaxis for 6 months to 2 years until ≥12 bleeding episodes had been treated with the product
  • Key inclusion criteria:
    • Aged ≥12 years
    • Basal plasma factor X concentration <5 IU/dL
    • Factor X replacement therapy for ≥1 spontaneous or menorrhagic bleeds in the past year
  • Key exclusion criteria:
    • History of factor X inhibitor development
    • Positive for factor X inhibitors at the screening visit
    • Known thrombocytopenia or clinically significant renal or liver disease

Results

Chart: Types of bleeds

*Includes cut/wound, central nervous system, epistaxis, forehead, gastrointestinal, intracranial, intraperitoneal, mouth, mucosal (not menorrhagia), pelvic, rectal, and unknown.

As categorized by the data review committee.

In this study, 16 patients experienced a total of 187 bleeds that were assessed by patients and an independent data review committee consisting of 3 hemophilia experts

  • 98% of bleeds were controlled with 1 or 2 infusions of COAGADEX

    Infusions of COAGADEX Needed to Control Bleeding

    • Mean dose per infusion was 25.3 IU/kg
    • Mean total dose per bleed was 30.4 IU/kg
  • 98.4% of bleeds were treated successfully (defined as “excellent” or “good”)

    Patient Assessment of Treatment Response (N=187 bleeds)

Reference: 1. Austin S, Norton M, et al. Safety and efficacy of FACTOR X, a new high-purity factor X concentrate: a phase 3 study in patients with hereditary factor X deficiency. Poster presented at the 9th Annual Scientific Symposium of the Hemostasis and Thrombosis Research Society (HTRS), New Orleans, April 16-18 2015. 2. COAGADEX® (Coagulation Factor X, Human) Prescribing Information. Durham, NC: BPL Limited. 2015.

Indications for COAGADEX

COAGADEX, a plasma-derived blood coagulation factor X concentrate, is indicated in adults and children (aged 12 years and above) with hereditary factor X deficiency for:

Perioperative management of bleeding in major surgery in patients with moderate and severe hereditary factor X deficiency has not been studied.

Important Safety Information for COAGADEX

COAGADEX is contraindicated in patients with known hypersensitivity to any of the components of the product.

Allergic type hypersensitivity reactions, including anaphylaxis, are possible with COAGADEX. If symptoms occur, patients should discontinue use of the product immediately and contact their physician.

The formation of neutralizing antibodies (inhibitors) to factor X is a possible complication in the management of individuals with factor X deficiency. Carefully monitor patients taking COAGADEX for the development of inhibitors by appropriate clinical observations and laboratory tests.

COAGADEX is made from human plasma and may contain infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, vCJD or CJD, have been associated with the use of COAGADEX.

In clinical studies, the most common adverse reactions (frequency ≥5% of subjects) with COAGADEX were infusion site erythema, infusion site pain, fatigue and back pain.

Please see complete Prescribing Information for COAGADEX.