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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02180763
Date of registration: 23/06/2014
Prospective Registration: Yes
Primary sponsor: Octapharma
Public title: Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps
Scientific 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.
Date of first enrolment: April 2014
Target sample size: 31
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02180763
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
France
Contacts
Name:     Boris Bienvenu, MD
Address: 
Telephone:
Email:
Affiliation:  Universtiy Hospital of Caen
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Primary Immunodeficiency (PID)
Intervention(s)
Biological: Gammanorm
Primary Outcome(s)
"Life Quality Index" (LQI) score (factor I: treatment interference) [Time Frame: 6 Months]
Secondary Outcome(s)
Secondary ID(s)
GAN-03
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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