Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02180763
• Date of registration: 23/06/2014
• Prospective Registration: No
• 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
• 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 ID(s)

GAN-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors