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

A Randomized, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL According to the Delivery Device: Injections Using Pump or Rapid Push.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02180763

Enrollment

Registered

2014-07-03

Start date

2014-04-30

Completion date

2017-08-26

Last updated

2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immunodeficiency (PID)

Keywords

Primary Immunodeficiency, PID

Brief summary

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.

Interventions

BIOLOGICALGammanorm

Sub-Q IgG

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Life Quality Index (LQI) score (factor I: treatment interference)	6 Months	Primary endpoint for assessment of patient's satisfaction regarding the treatment delivery device (pump or syringe) will be the Life Quality Index (LQI) score (factor I: treatment interference) at the end of each 3-month treatment period.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026