World Health Organization site
Skip Navigation Links

Main
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: EUCTR
Last refreshed on: 30 April 2018
Main ID:  EUCTR2014-003746-27-DE
Date of registration: 01/12/2014
Prospective Registration: Yes
Primary sponsor: Octapharma Pharmazeutika Produktionsges.m.b.H, Oberlaaer Strasse 235, A-1100 Vienna, Austria
Public 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 an infusion pump or syringe
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 - Gammanorm in immunodeficient patients: quality of life using infusion by pump or rapid push
Date of first enrolment: 15/04/2015
Target sample size: 40
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003746-27
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): yes
Countries of recruitment
Australia Germany Italy United Kingdom
Contacts
Name: Clinical Research and Development   
Address:  Oberlaaer Strasse 235 1100 Vienna Austria
Telephone: 431610329249
Email:
Affiliation:  Octapharma Pharmazeutika Produktionsges.m.b.H.
Name: Clinical Research and Development   
Address:  Oberlaaer Strasse 235 1100 Vienna Austria
Telephone: 431610329249
Email:
Affiliation:  Octapharma Pharmazeutika Produktionsges.m.b.H.
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
immunodeficiency syndrome
MedDRA version: 19.1 Level: HLT Classification code 10036700 Term: Primary immunodeficiency syndromes System Organ Class: 100000004870
Therapeutic area: Body processes [G] - Immune system processes [G12]
Intervention(s)

Trade Name: Gammanorm 165 mg/mL
Pharmaceutical Form:

Primary Outcome(s)
Main Objective: To compare patient satisfaction score
Primary end point(s): patient satisfaction score
Secondary Objective: additional life quality scores
Timepoint(s) of evaluation of this end point: see protocol
Secondary Outcome(s)
Secondary end point(s): additional life quality scores
Timepoint(s) of evaluation of this end point: see protocol
Secondary ID(s)
GAN-06
ISRCTN55938644
Source(s) of Monetary Support
Octapharma Pharmazeutika Produktionsges.m.b.H, Oberlaaer Strasse 235, A-1100 Vienna, Austria
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history