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

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.

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Key information

Conditions

Primary Immunodeficiency (PID) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Haut-Leveque Hospital, Bordeaux, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gammanorm

Biological

Sub-Q IgG

Primary outcomes

"Life Quality Index" (LQI) score (factor I: treatment interference)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Octapharma

Industry

Registry information

Official study title

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.

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Jul 3, 2014
Registry last updated: Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed