Date: 2015-09-01
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Bio Products Laboratory (UK)
Product: Subgam®VF
Action
mechanism: immunoglobulin. Subgam-VF is a 16% immunoglobulin product made from human plasma specifically for subcutaneous use.
Disease: primary immune deficiency disorders, common variable immunodeficiency, X-linked agammaglobulinaemia, hyperimmunoglobulin M syndrome
Therapeutic area: Immunological diseases
Country: USA
Trial
details: The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin (IGIV) therapy. (NCT01884311)
Latest
news: * On September 1, 2015, Bio Products Laboratory (BPL), a leading manufacturer of plasma-derived protein therapies, announced that the first subject has enrolled in SCIG03, a clinical trial evaluating the safety and pharmacokinetics of Subgam®VF, 16% liquid immunoglobulin for the treatment of primary immunodeficiency. The trial, titled, “A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subgam®VF in Primary Immunodeficiency Diseases” will take place in the U.S. and will form the basis of a biologics license application for U.S. marketing authorization. The trial will enroll 35 patients with primary immunodeficiency and treat them for up to 26 weeks. The pharmacokinetics of Subgam®VF will be assessed and will be compared to previous studies.
