30
Participants
Start Date
July 29, 2015
Primary Completion Date
December 11, 2017
Study Completion Date
December 11, 2017
Chrono Super PID then Generic Syringe-Gammanorm
"Each patient will receive the study treatment of Gammanorm using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design:~• pump and then syringe~The use of automatic, programmable, compact pumps (such as CRONO SUPER PID) allows patients to remain mobile without interrupting their activities. Patients can infuse several sites simultaneously with infusion rates of up to 40 mL/h at 2 to 4 sites (abdomen, thighs, upper arms, lower back).~Rapid and manual administration of SCIg using a syringe could therefore represent an alternative method by decreasing the duration of administration (around 10 minutes per injection at 1 or 2 sites simultaneously). The injection is self-administered by the patient. The infusion rate usually is 1 to 2 mL/min. The use of low viscosity products could facilitate injection"
Generic Syringe then Chrono Super PID-Gammanorm
"Each patient will receive the study treatment using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design:~• syringe and then pump.~The use of automatic, programmable, compact pumps (such as CRONO SUPER PID) allows patients to remain mobile without interrupting their activities. Patients can infuse several sites simultaneously with infusion rates of up to 40 mL/h at 2 to 4 sites (abdomen, thighs, upper arms, lower back).~Rapid and manual administration of SCIg using a syringe could therefore represent an alternative method by decreasing the duration of administration (around 10 minutes per injection at 1 or 2 sites simultaneously). The injection is self-administered by the patient. The infusion rate usually is 1 to 2 mL/min. The use of low viscosity products could facilitate injection"
Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica, Padua
CampbelltownHospital, Campbelltown
Canberra Hospital, Canberra
University Medical Centre Freiburg, Freiburg im Breisgau
"Municipal Hospital St. Georg", Leipzig
"Policlinic Umberto I - Universita di Roma Sapienza, Clinical Immunology", Rome
University Hospitals Birmingham, Birmingham
University Hospital of Wales, Cardiff
- The Royal London Hospital, London
The Royal Free, London
John Radcliff Hospital, Oxford
Derriford Hospital, Plymouth
Lead Sponsor
Octapharma
INDUSTRY