Clinical trial NCT02503293: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Immunodeficiency
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2015-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: To compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL by delivery device used.
timeFrame: Participants will be followed for a total of 6 months
Secondary outcomes:
measure: To compare the other quality of life scores
timeFrame: Participants will be followed for a total of 6 months
Other outcomes:
Locations:
city: Campbelltown
country: Australia
facility: CampbelltownHospital
city: Canberra
country: Australia
facility: Canberra Hospital
city: Freiburg
country: Germany
facility: University Medical Centre Freiburg
city: Leipzig
country: Germany
facility: Municipal Hospital "St. Georg"
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica
city: Rome
country: Italy
facility: Policlinic Umberto I - Universita di Roma "Sapienza", Clinical Immunology
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: London
country: United Kingdom
facility: - The Royal London Hospital
city: London
country: United Kingdom
facility: The Royal Free
city: Oxford
country: United Kingdom
facility: John Radcliff Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: Centre of Chronic Immunodeficiency, University Medical Centre Freiburg, Breisacher
name: Klaus Warnatz, MD
role: PRINCIPAL_INVESTIGATOR
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