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

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

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003746-27-DE

Enrollment

Registered

2014-12-01

Start date

2015-04-15

Completion date

Unknown

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immunodeficiency syndrome MedDRA version: 19.1 Level: HLT Classification code 10036700 Term: Primary immunodeficiency syndromes System Organ Class: 100000004870

Interventions

Trade Name: Gammanorm 165 mg/mL Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare patient satisfaction score;Secondary Objective: additional life quality scores;Primary end point(s): patient satisfaction score ;Timepoint(s) of evaluation of this end point: see protocol	—

Secondary

Measure	Time frame
Secondary end point(s): additional life quality scores;Timepoint(s) of evaluation of this end point: see protocol	—

Countries

Australia, Germany, Italy, United Kingdom

Contacts

Public ContactClinical Research and Development

Octapharma Pharmazeutika Produktionsges.m.b.H.

431610329249

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026