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

Primary Immunodeficiency (PID) Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180763
• Other study ID #: GAN-03
• Status: Completed
• Phase: Phase 4
• Start date: April 2014
• Est. completion date: August 26, 2017

Study information

• Verified date: August 2018
• Source: Octapharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 26, 2017
• Est. primary completion date: August 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immunodeficiency (PID)

Intervention

Biological:
• Gammanorm
Sub-Q IgG

Locations

Country	Name	City	State
France	Haut-Leveque Hospital	Bordeaux
France	University Hospital of Caen	Caen
France	University Hospital of Lille	Lille
France	Hospital Dupuytren	Limoges
France	Clinique Mutualiste	Lyon
France	University Hospital of Reims	Reims
France	University Hospital of Toulouse	Toulouse
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Life Quality Index" (LQI) score (factor I: treatment interference)	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.	6 Months