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: 07 Nov 2016
At a glance
- Drugs Rabies immune globulin (Primary) ; Rabies vaccine
- Indications Rabies
- Focus Pharmacodynamics; Registrational
- Sponsors Kamada
- 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.
- 23 Dec 2015 According to a Kamada media release, primary endpoint Immunoglobulin G levels (Anti-rabies IgG concentration assessed at 6 months after dosing.) has been met.