A Prospective, Randomized, Double-Blind, Non Inferiority, Phase II/III Study of the Safety and Effectiveness of Simulated Post-Exposure Prophylaxis With Kamada Human Rabies Immune Globulin (KamRAB) With Co-administration of Active Rabies Vaccine in Healthy Subjects

Trial Profile

A Prospective, Randomized, Double-Blind, Non Inferiority, Phase II/III Study of the Safety and Effectiveness of Simulated Post-Exposure Prophylaxis With Kamada Human Rabies Immune Globulin (KamRAB) With Co-administration of Active Rabies Vaccine in Healthy Subjects

Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 25 Aug 2017

At a glance

  • Drugs Rabies immune globulin (Primary) ; Rabies vaccine
  • Indications Rabies
  • Focus Pharmacodynamics; Registrational
  • Sponsors Kamada
  • Most Recent Events

    • 25 Aug 2017 According to a Kedrion media release, based on the data from this trial, KEDRAB [rabies immune globulin (Human)] has received U.S. Food and Drug Administration (FDA) approval for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine.
    • 07 Nov 2016 According to Kedrion Biopharma and Kamada media release, based on the results from this study, the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for a human anti-rabies immunoglobulin (IgG) therapy and FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2017.
    • 01 Sep 2016 According to a Kamada media release, based on the results from this study the company has filed a Biological License Application (BLA) with the U.S. Food and Drug Administration (FDA) for a post-exposure treatment for rabies, a life-threatening condition. The company expects a regulatory decision from the FDA on the BLA in mid-2017.
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