Date: 2014-03-04
Type of information:
phase: 2-3
Announcement: completion of patient recruitment
Company: Kamada (Israel)
Product: KamRAB®
Action mechanism:
Disease: post-exposure prophylaxis (PEP) for rabies
Therapeutic area: Infectious diseases
Country: USA
Trial
details: The Phase 2/3 clinical trial is a prospective, randomized, double-blind, non-inferiority study of 118 healthy subjects to evaluate the safety and effectiveness of KamRAB. The study assesses whether KamRAB interferes with the development of self-active antibodies. The primary and secondary endpoints of this study are pharmacokinetic (PK) parameters of anti-rabies IgG levels in serum at different time points. In addition, safety and tolerability are assessed. (NCT02040090)
Latest
news: * On March 4, 2014, Kamada, a plasma-derived protein therapeutics company, focused on orphan indications, has announced that it has completed enrollment in its U.S. Phase 2/3 clinical trial of KamRAB® as a post-exposure prophylaxis (PEP) for rabies. KamRAB is Kamada\'s human rabies immune globulin, currently marketed for this indication in 6 countries worldwide. Kamada has a strategic agreement with Kedrion S.p.A for the clinical development and marketing of KamRAB in the U.S.The Phase 2/3 clinical trial is a prospective, randomized, double-blind, non-inferiority study of 118 healthy subjects to evaluate the safety and effectiveness of KamRAB. The study assesses whether KamRAB interferes with the development of self-active antibodies.
