Safety study of Octagam 10% for replacement therapy in PID

• Research type

  Research Study

• Full title

  Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases

• IRAS ID

  40946

• Contact name

  Stephen Jolles

• Sponsor organisation

  Octapharma AG

• Eudract number

  2007-002611-27

• ISRCTN Number

  ISRCTN63491981

• Research summary

  This study is designed to assess the safety of Octagam 10% for use in replacement therapy in patients with primary immunodeficiency disease (PID), which is where patients are more likely to get an infection as the body's immune system is unable to function properly. The study will also compare the pharmacokinetics of Octagam 10% (how the drug is processed) against Octagam 5%. Comparisons will be made as to how effectively Octagam 10% fights infections and the rate of infections, the levels of antibodies within the body between treatments, the use of antibiotics and monitoring of days absent from work/school. 45 patients who have been diagnosed with PID (as per World Health Organisation definition) and are requiring immunoglobulin (antibody) replacement therapy, but who have previously used Octagam 5%, will be enrolled into the study, ranging between the ages of 2 and 75. Study duration for each patient will be approximately 13 months; involving a total of between 13 and 17 infusions (infusions will take place every 3-4 weeks). Each infusion (including monitoring of vital signs before discharge) will last about 1 and half hours up to about 3 hours, depending on the dosage and time in study.

• REC name

  Wales REC 2

• REC reference

  10/WSE02/13

• Date of REC Opinion

  12 Feb 2010

• REC opinion

  Favourable Opinion