A 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

Last updated: April 5, 2019
Sponsor: Octapharma
Overall Status: Completed

Phase

4

Condition

Hypogammaglobulinemia

Hiv Infections

Primary Immunodeficiency

Treatment

N/A

Clinical Study ID

NCT02503293
GAN-06
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Adult patients (≥ 18 years).

  • Presenting with primary immunodeficiency.

  • Having received subcutaneous injections of immunoglobulin at home using an automaticpump or syringe for at least 1 month at the time of inclusion.

  • For whom the investigator decides to maintain immunoglobulin replacement therapy withsubcutaneous injections of Gammanorm® 165 mg/mL at home.

  • Freely given written informed consent from patient.

  • Women of childbearing potential must have a negative result on a pregnancy test (humanchorionic gonadotropine [HCG]-based assay) and need to practice contraception using amethod of proven reliability for the duration of the study.

Exclusion

Exclusion Criteria:

• Participating in another interventional clinical study and receiving investigationalmedicinal product within three months before study entry.

Study Design

Total Participants: 30
Study Start date:
July 29, 2015
Estimated Completion Date:
December 11, 2017

Connect with a study center

  • CampbelltownHospital

    Campbelltown, NSW 2560
    Australia

    Site Not Available

  • Canberra Hospital

    Canberra, ACT 2605
    Australia

    Site Not Available

  • University Medical Centre Freiburg

    Freiburg, D-79106
    Germany

    Site Not Available

  • Municipal Hospital "St. Georg"

    Leipzig, D-04129
    Germany

    Site Not Available

  • Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica

    Padova, 35128
    Italy

    Site Not Available

  • Policlinic Umberto I - Universita di Roma "Sapienza", Clinical Immunology

    Rome, 00161
    Italy

    Site Not Available

  • University Hospitals Birmingham

    Birmingham, B15 2GW
    United Kingdom

    Site Not Available

  • University Hospital of Wales

    Cardiff, CF144XW
    United Kingdom

    Site Not Available

  • - The Royal London Hospital

    London, E12ES
    United Kingdom

    Site Not Available

  • The Royal Free

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • John Radcliff Hospital

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

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