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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:  NCT02503293
Date of registration: 01/07/2015
Prospective Registration: Yes
Primary sponsor: Octapharma
Public title: A Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push
Scientific title: A Randomised, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push
Date of first enrolment: July 29, 2015
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02503293
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Australia Germany Italy United Kingdom
Contacts
Name:     Klaus Warnatz, MD
Address: 
Telephone:
Email:
Affiliation:  Centre of Chronic Immunodeficiency, University Medical Centre Freiburg, Breisacher
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 or syringe 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.

- Freely given written informed consent from patient.

- Women of childbearing potential must have a negative result on a pregnancy test (human
chorionic gonadotropine [HCG]-based assay) and need to practice contraception using a
method of proven reliability for the duration of the study.

Exclusion Criteria:

• Participating in another interventional clinical study and receiving investigational
medicinal product within three months before study entry.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Primary Immunodeficiency
Intervention(s)
Device: Chrono Super PID then Generic Syringe-Gammanorm
Device: Generic Syringe then Chrono Super PID-Gammanorm
Primary Outcome(s)
To compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL by delivery device used. [Time Frame: Participants will be followed for a total of 6 months]
Secondary Outcome(s)
To compare the other quality of life scores [Time Frame: Participants will be followed for a total of 6 months]
Secondary ID(s)
GAN-06
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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