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

• 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
• Affiliation: Octapharma Pharmazeutika Produktionsges.m.b.H.

• Name: Clinical Research and Development
• 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)

Primary end point(s): patient satisfaction score

Main Objective: To compare 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)

ISRCTN55938644

GAN-06

Source(s) of Monetary Support

Octapharma Pharmazeutika Produktionsges.m.b.H, Oberlaaer Strasse 235, A-1100 Vienna, Austria