Extension study of subcutaneous IgPro20 in PID

• Research type

  Research Study

• Full title

  A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency (IgPro20 EU Extension Study)

• IRAS ID

  5389

• Sponsor organisation

  CSL Behring AG

• Eudract number

  2008-000830-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The same subjects with primary Immunodeficiency (PID) who are participating in study ZLB06_001CR will be invited at the end of the study period to continue with the subcutaneous home treatment of IgPro20 by participating in the extension study ZLB07_002CR.The purpose of the extension study is to assess the long-term efficacy, tolerability, and safety of IgPro20 taking also into consideration the results of long-term health-related quality of life (HRQL).In this study the planned weekly dose for the subject of IgPro20 injected subcutaneously will be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR.The subject can choose his/her dose schedule individually, spreading the weekly dose overiseveral days providing however that the total weekly dose remains unchanged.The individual duration of the extension study depends on the time slot between last infusion within study ZLB06_001CR and the availability of IgPro20 on the European market.The study duration is expected not to exceed 30 months.

• REC name

  Wales REC 3

• REC reference

  08/MRE09/73

• Date of REC Opinion

  10 Dec 2008

• REC opinion

  Further Information Favourable Opinion