A 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

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 29, 2015

Primary Completion Date

December 11, 2017

Study Completion Date

December 11, 2017

Conditions
Primary Immunodeficiency
Interventions
DEVICE

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"

DEVICE

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"

Trial Locations (12)

35128

Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica, Padua

NSW 2560

CampbelltownHospital, Campbelltown

ACT 2605

Canberra Hospital, Canberra

D-79106

University Medical Centre Freiburg, Freiburg im Breisgau

D-04129

"Municipal Hospital St. Georg", Leipzig

00161

"Policlinic Umberto I - Universita di Roma Sapienza, Clinical Immunology", Rome

B15 2GW

University Hospitals Birmingham, Birmingham

CF144XW

University Hospital of Wales, Cardiff

E12ES

- The Royal London Hospital, London

NW3 2QG

The Royal Free, London

OX3 9DU

John Radcliff Hospital, Oxford

PL6 8DH

Derriford Hospital, Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Octapharma

INDUSTRY