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.
1 other identifier
interventional
31
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2014
Typical duration for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
July 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2017
CompletedSeptember 5, 2018
August 1, 2018
2.4 years
June 23, 2014
August 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
"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
Study Arms (1)
Gammanorm® 165 mg/mL
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult patients (≥ 18 years)
- Presenting with primary immunodeficiency
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Octapharmalead
Study Sites (8)
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, France
Related Publications (1)
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.
PMID: 29855752DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Boris Bienvenu, MD
Universtiy Hospital of Caen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2014
First Posted
July 3, 2014
Study Start
April 1, 2014
Primary Completion
August 28, 2016
Study Completion
August 26, 2017
Last Updated
September 5, 2018
Record last verified: 2018-08