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

Octapharma

Status and phase: Completed; Phase 4

Conditions: Primary Immunodeficiency

Treatments: Device: Generic Syringe then Chrono Super PID-Gammanorm; Device: Chrono Super PID then Generic Syringe-Gammanorm

Study type: Interventional

Funder types: Industry

Identifiers

NCT02503293

GAN-06

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (≥ 18 years).
• Presenting with primary immunodeficiency.
• Having received subcutaneous injections of immunoglobulin at home using an automatic pump or syringe for at least 1 month at the time of inclusion.
• For whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of Gammanorm® 165 mg/mL at home.
• Freely given written informed consent from patient.
• Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropine [HCG]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study.

Exclusion criteria

• Participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Chrono Super PID then Generic Syringe - Gammanorm

Other group

Description:

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: • Chrono Super PID then Generic Syringe-Gammanorm

Treatment:

Device: Chrono Super PID then Generic Syringe-Gammanorm

Generic Syringe then Chrono Super PID - Gammanorm

Other group

Description:

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: • Generic Syringe then Chrono Super PID-Gammanorm

Treatment:

Device: Generic Syringe then Chrono Super PID-Gammanorm