Back to resultsGammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps
Primary Purpose
Primary Immunodeficiency (PID)
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Gammanorm
Sponsored by
About this trial
This is an interventional treatment trial for Primary Immunodeficiency (PID) focused on measuring Primary Immunodeficiency, PID
Eligibility Criteria
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
Sites / Locations
- Haut-Leveque Hospital
- University Hospital of Caen
- University Hospital of Lille
- Hospital Dupuytren
- Clinique Mutualiste
- University Hospital of Reims
- University Hospital of Toulouse
- University Hospital of Tours
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gammanorm® 165 mg/mL
Arm Description
Outcomes
Primary Outcome Measures
"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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02180763
Brief Title
Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 28, 2016 (Actual)
Study Completion Date
August 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Octapharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immunodeficiency (PID)
Keywords
Primary Immunodeficiency, PID
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gammanorm® 165 mg/mL
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Gammanorm
Intervention Description
Sub-Q IgG
Primary Outcome Measure Information:
Title
"Life Quality Index" (LQI) score (factor I: treatment interference)
Description
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.
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Bienvenu, MD
Organizational Affiliation
Universtiy Hospital of Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haut-Leveque Hospital
City
Bordeaux
Country
France
Facility Name
University Hospital of Caen
City
Caen
Country
France
Facility Name
University Hospital of Lille
City
Lille
Country
France
Facility Name
Hospital Dupuytren
City
Limoges
Country
France
Facility Name
Clinique Mutualiste
City
Lyon
Country
France
Facility Name
University Hospital of Reims
City
Reims
Country
France
Facility Name
University Hospital of Toulouse
City
Toulouse
Country
France
Facility Name
University Hospital of Tours
City
Tours
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29855752
Citation
Bienvenu B, Cozon G, Mataix Y, Lachaud D, Alix A, Hoarau C, Antier D, Hachulla E, Brice S, Viallard JF, Tamisier S, Fauchais AL, Renon-Carron F, Clerson P, Fardini Y, Crave JC, Miossec P. Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients. J Clin Immunol. 2018 May;38(4):503-512. doi: 10.1007/s10875-018-0507-x. Epub 2018 May 31.
Results Reference
derived
Learn more about this trial
Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps
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