A Prospective, Open-Label, Multicenter Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Therapure PlasmaCap IG in Adults and Children With Primary Immune Deficiency Diseases
Phase of Trial: Phase III
Latest Information Update: 25 Sep 2018
At a glance
- Drugs Immune globulin (Primary)
- Indications Immunodeficiency disorders
- Focus Registrational; Therapeutic Use
- Sponsors Evolve Biologics; Therapure Biopharma
- 25 Sep 2018 According to an Evolve Biologics media release, More than 80% of the required infusions in the adult portion of the study have now been administered;The first adult patient dosed is expected to finish the study within the next two weeks, following 12 months of PlasmaCap IG therapy.
- 04 May 2018 According to an Evolve Biologics media release, based on the data from the adult patients, the company plans to submit a Biologics License Application (BLA) to the FDA.
- 04 May 2018 According to an Evolve Biologics media release, the company has completed the enrollment of the adult patients in Feb 2018 and dosed the first pediatric patient in this study. The study received approval to proceed from the U.S. FDA and Health Canada in 2017. Richard L. Wasserman, M.D.,Ph.D., Medical Director of Pediatric Allergy and Immunology at Medical City Children's Hospital (Texas) is a principal investigator of the study.