Techspec schreef op 29 januari 2019 22:44:
A Study to Evaluate the Benefit of RUCONEST® in Subjects With CVID Who Experience ADRs Related to IVIG Infusions
clinicaltrials.gov/ct2/show/record/NC...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.
Ik ben er nog even wat verder ingedoken en inderdaad, als sponsor staat niet Pharming vermeld maar het IMMUNOe Research Center.
Dat is waarschijnlijk ook de reden dat Pharming deze niet vermeld heeft op 21 juni.
immunoeresearch.comIMMUNOe Research Centers is a private research organization conducting Phase I through Phase IV clinical research trials, with a focus on biologic therapies and Immune related diseases. We possess many attributes that have placed us as one of the most trusted, valued and knowledgeable associates among the leading pharmaceutical companies in the country.
OUR CAPABILITIES
• Our dedicated Infusion Center allows for infusion and IVIG capabilities
• We have a unique focus on the immune system and its relationship with your overall health
• IMMUNOe is linked with several other clinical research centers around the world
De studie loopt in Amerika en is aangemeld bij de FDA. De richtlijnen van een fase 4 onderzoek door de FDA;
Phase 4
A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.
Ik weet niet in hoeverre Pharming in contact staat met het IMMUNOe Research Center / Principal investigator MD Isaac Melamed omtrent deze studie.
Pharming komt op een steeds breder vlak in beeld en het goede nieuws is dat Pharming vooruit stoomt naar betere, mooie tijden voor zowel Pharming, de patiënten en ons beleggers...
Deze studie zal afgerond zijn in juni 2019......