Comparison of quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm administered using a pump or a syringe for rapid manual administratio

Phase 3

Completed

• Conditions: Primary immunodeficiency; Haematological Disorders

• Registration Number: ISRCTN55938644
• Lead Sponsor: Octapharma Pharmazeutika Prod.Ges.m.b.H.

Brief Summary

Results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-15
• Study Completion: 2017-12-11
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Adult patients (= 18 years).
2. Presenting with primary immunodeficiency.
3. Having received subcutaneous injections of immunoglobulin at home using an automatic pump or syringe for at least 1 month at the time of inclusion.
4. For whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of Gammanorm® 165 mg/mL at home.
5. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient satisfaction is measured using the life quality index (LQI) questionnaire at the end of each 3 month treatment period.