On March 30, the first subject has been included in Kedrion’s Rh&Life clinical study.
Rh&Life stands for Rhesus and Life (protection of life). It is a phase III, open-label, uncontrolled, multicenter study to assess efficacy, pharmacokinetics and safety of an Anti-D Immunoglobulin in the prevention of Rh(D) isoimmunization in Rh(D) negative women pregnant with Rh(D) positive fetuses.
Rh&Life is set to enroll 200 subjects over 18 sites in 5 countries (Italy, Poland, Hungary, Czech Republic and Russia). Efficacy endpoints of the study are incidence of Anti-D antibodies evaluated at 12 and 24 weeks after treatment.
The Rh&Life study results will enable Kedrion Biopharma to extend further the adoption of Anti-D Immunoglobulins both in the EU and extra-EU, providing Rh immunoprophylaxis to a larger number of mothers and children.
About Rh Disease
Hemolytic Disease of Fetus and Newborn (HDFN, also known as Erythroblastosis Fetalis or simply, Rh Disease) happens when an Rh negative mother has a baby with an Rh positive father. If the Rh negative mother has been previously sensitized to Rh positive blood, her immune system will make antibodies to attack her baby. Symptoms may vary from yellow coloring of the skin and whites of the eyes (jaundice), anemia up to severe neurological disorders at birth and later consequences including deafness, cerebral palsy, other sensorineural deficits, and mental retardation.
Rh Disease is a preventable disease, but worldwide hundreds of thousands babies are still at risk because of a lack of awareness about access to and/or availability of appropriate immunoprophylaxis with plasma polyclonal anti D immunoglobulin.
To learn more about Kedrion’s commitment to Mother & Child Health, please visit our dedicated page.