Techspec schreef op 7 juli 2018 11:47:
[...]
Beste Forest,
A Study to Evaluate the Benefit of RUCONEST® in Subjects With CVID Who Experience ADRs Related to IVIG Infusions
Brief summary;
Patients receiving intravenous immunoglobulin (IVIG) therapy for primary immunodeficiency, specifically common variable immunodeficiency (CVID), may experience adverse drug reactions (ADRs). The mechanism of the ADR is unknown. Currently, the standard practice for these patients is to change from IV to subcutaneous IG (SCIG) but because of the need of immunomodulation or patient preference, SCIG may not be an option. Data has shown that some levels of complement decrease from pre- to post-infusion of IVIG. This study is to determine if replacing this complement protein may ameliorate ADRs.
Betreft een onderzoek om vast te stellen of door het toedienen van Ruconest, voorafgaand aan het toedienen van medicatie ter bestrijden van ziektes door een gebrekkig immuunsysteem, bijwerkingen worden voorkomen.
FDA > Phase IV clinical trials can be conducted to find new markets for competitive analysis on the drug or treatment.
The drug / het medicijn Ruconest is al op de markt en daarom zijn fases 1 t/m 3 overgeslagen.