A Phase 3, Multinational, Multicenter, Open-Label Study of the Safety, Tolerability, Efficacy, and PK of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10% in Adults and Children With PID
Phase of Trial: Phase III
Latest Information Update: 22 Nov 2017
At a glance
- Drugs Immune globulin (Primary)
- Indications Immunodeficiency disorders
- Focus Registrational; Therapeutic Use
- Sponsors ProMetic Life Sciences
- 22 Nov 2017 According to a Prometic media release, interim results from this trial are sufficient to complete the clinical portion of the New Drug Submission (NDS) with Health Canada.
- 22 Nov 2017 Interim six-month data presented in a Prometic media release.
- 02 Mar 2017 Planned End Date changed from 1 Mar 2018 to 1 May 2018.