Gammanorm in immunodeficient pts using infusion by pump or rapid push
Research type
Research Study
Full title
A randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices: injections using pump or rapid push
IRAS ID
172127
Contact name
Birgit Taumberger
Contact email
Sponsor organisation
Octapharma Pharmazeutika Produktionsgesellschaft mbH
Eudract number
2014-003746-27
Duration of Study in the UK
1 years, 10 months, 15 days
Research summary
This is a randomised study that involves the use of two different delivery methods to administer IgG replacement therapy to patients diagnosed with Primary Immunodeficiency (PID), which is a condition where the body cannot fight bacteria and viruses like most people can.
Randomisation is a process where the group to which you are assigned is selected by chance. There are two groups in this study: In Group 1 patients will be treated with subcutaneous injections of Gammanorm® 165 mg/mL for 3 months by pump and then for 3 months by syringe; In Group 2 patients will be treated with injections of Gammanorm® for 3 months by syringe and then for 3 months by pump. Thus, patients will use both methods of treatment in a row. It is the aim of the cross-over design of the study for the treatment methods to change for each patient during the study. The two treatment periods will be performed without time-gap in between and the total length of the study treatment will be 6 months for each patient. The randomisation scheme is 1:1 that means you have the same chance to be in either group. The decision as to which treatment the patient receives will be random, like flipping a coin.
Patients will have been treated with subcutaneous infusion of IgG at home using an automatic pump or syringe for at least 30 days before the study and the patients will continue treatment at home during the study.
This study aims to assess patients’ satisfaction with IgG replacement therapy given with the two different delivery methods, including patients’ quality of life. It is hoped to show that the administration using a syringe has no effect in terms of patient satisfaction compared to administration using a pump.REC name
Wales REC 3
REC reference
15/WA/0047
Date of REC Opinion
16 Apr 2015
REC opinion
Further Information Favourable Opinion