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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

Sponsor
Octapharma (Industry)
Overall Status
Completed
CT.gov ID
NCT02503293
Collaborator
(none)
30
Enrollment
12
Locations
2
Arms
28.5
Actual Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Chrono Super PID then Generic Syringe-Gammanorm
  • Device: Generic Syringe then Chrono Super PID-Gammanorm
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jul 29, 2015
Actual Primary Completion Date :
Dec 11, 2017
Actual Study Completion Date :
Dec 11, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: Chrono Super PID then Generic Syringe - Gammanorm

Each patient will receive the study treatment using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design: • Chrono Super PID then Generic Syringe-Gammanorm

Device: Chrono Super PID then Generic Syringe-Gammanorm
Each patient will receive the study treatment of Gammanorm using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design: • pump and then syringe The use of automatic, programmable, compact pumps (such as CRONO SUPER PID) allows patients to remain mobile without interrupting their activities. Patients can infuse several sites simultaneously with infusion rates of up to 40 mL/h at 2 to 4 sites (abdomen, thighs, upper arms, lower back). Rapid and manual administration of SCIg using a syringe could therefore represent an alternative method by decreasing the duration of administration (around 10 minutes per injection at 1 or 2 sites simultaneously). The injection is self-administered by the patient. The infusion rate usually is 1 to 2 mL/min. The use of low viscosity products could facilitate injection
Other Names:
  • Automatic Programable compact pump - Chrono Super PID Pump

    		•
    Other: Generic Syringe then Chrono Super PID - Gammanorm

    Each patient will receive the study treatment using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design: • Generic Syringe then Chrono Super PID-Gammanorm

    Device: Generic Syringe then Chrono Super PID-Gammanorm
    Each patient will receive the study treatment using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design: • syringe and then pump. The use of automatic, programmable, compact pumps (such as CRONO SUPER PID) allows patients to remain mobile without interrupting their activities. Patients can infuse several sites simultaneously with infusion rates of up to 40 mL/h at 2 to 4 sites (abdomen, thighs, upper arms, lower back). Rapid and manual administration of SCIg using a syringe could therefore represent an alternative method by decreasing the duration of administration (around 10 minutes per injection at 1 or 2 sites simultaneously). The injection is self-administered by the patient. The infusion rate usually is 1 to 2 mL/min. The use of low viscosity products could facilitate injection
    Other Names:
  • Automatic Programable compact pump - Chrono Super PID Pump

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL by delivery device used. [Participants will be followed for a total of 6 months]

      Each patient will be treated for two consecutive periods of three months each according to the sequence assigned based on the cross-over design (syringe and then pump, or pump and then syringe) without any intermediate washout period. The total duration of study treatment will therefore be 6 months for each patient. Assessment will be conducted via the LQI scale.

    Secondary Outcome Measures

    1. To compare the other quality of life scores [Participants will be followed for a total of 6 months]

      Each patient will be treated for two consecutive periods of three months each according to the sequence assigned based on the cross-over design (syringe and then pump, or pump and then syringe) without any intermediate washout period. The total duration of study treatment will therefore be 6 months for each patient. Assessment will be conducted via the LQI scale factors II and III Patient quality of life will be assessed via SF-36 scale. Patient satisfaction will be assessed via TSQM-11 scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    • Freely given written informed consent from patient.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CampbelltownHospital Campbelltown Australia NSW 2560
    2 Canberra Hospital Canberra Australia ACT 2605
    3 University Medical Centre Freiburg Freiburg Germany D-79106
    4 Municipal Hospital "St. Georg" Leipzig Germany D-04129
    5 Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica Padova Italy 35128
    6 Policlinic Umberto I - Universita di Roma "Sapienza", Clinical Immunology Rome Italy 00161
    7 University Hospitals Birmingham Birmingham United Kingdom B15 2GW
    8 University Hospital of Wales Cardiff United Kingdom CF144XW
    9 - The Royal London Hospital London United Kingdom E12ES
    10 The Royal Free London United Kingdom NW3 2QG
    11 John Radcliff Hospital Oxford United Kingdom OX3 9DU
    12 Derriford Hospital Plymouth United Kingdom PL6 8DH

    Sponsors and Collaborators

    • Octapharma

    Investigators

    • Principal Investigator: Klaus Warnatz, MD, Centre of Chronic Immunodeficiency, University Medical Centre Freiburg, Breisacher

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Octapharma
    ClinicalTrials.gov Identifier:
    NCT02503293
    Other Study ID Numbers:
    • GAN-06
    First Posted:
    Jul 20, 2015
    Last Update Posted:
    Apr 9, 2019
    Last Verified:
    Apr 1, 2019
    Additional relevant MeSH terms:
    Primary Immunodeficiency Diseases
    Immunologic Deficiency Syndromes

    Study Results

    No Results Posted as of Apr 9, 2019