Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps

Octapharma

Status and phase: Completed; Phase 4

Conditions: Primary Immunodeficiency (PID)

Treatments: Biological: Gammanorm

Study type: Interventional

Funder types: Industry

Identifiers

NCT02180763

GAN-03

Details and patient eligibility

About

The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.

Enrollment: 31 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 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
• Having signed an informed consent form

Exclusion criteria

• Patient currently participating in another interventional study at the time of inclusion

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Gammanorm® 165 mg/mL

Experimental group

Treatment:

Biological: Gammanorm