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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

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ClinicalTrials.gov Identifier: NCT02503293
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Octapharma

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
Primary Immunodeficiency Device: Chrono Super PID then Generic Syringe-Gammanorm Device: Generic Syringe then Chrono Super PID-Gammanorm Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : July 29, 2015
Actual Primary Completion Date : December 11, 2017
Actual Study Completion Date : December 11, 2017


Arm Intervention/treatment
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 Name: Automatic Programable compact pump - Chrono Super PID Pump

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 Name: Automatic Programable compact pump - Chrono Super PID Pump




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. [ Time Frame: 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 [ Time Frame: 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503293


Locations
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Australia
CampbelltownHospital
Campbelltown, Australia, NSW 2560
Canberra Hospital
Canberra, Australia, ACT 2605
Germany
University Medical Centre Freiburg
Freiburg, Germany, D-79106
Municipal Hospital "St. Georg"
Leipzig, Germany, D-04129
Italy
Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica
Padova, Italy, 35128
Policlinic Umberto I - Universita di Roma "Sapienza", Clinical Immunology
Rome, Italy, 00161
United Kingdom
University Hospitals Birmingham
Birmingham, United Kingdom, B15 2GW
University Hospital of Wales
Cardiff, United Kingdom, CF144XW
- The Royal London Hospital
London, United Kingdom, E12ES
The Royal Free
London, United Kingdom, NW3 2QG
John Radcliff Hospital
Oxford, United Kingdom, OX3 9DU
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Octapharma
Investigators
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Principal Investigator: Klaus Warnatz, MD Centre of Chronic Immunodeficiency, University Medical Centre Freiburg, Breisacher
Publications:
Haag, S., XIIth Meeting of the European Society for Immunodeficiencies, October 4-7, 2006, Budapest, Hungary. 2012.
Chapiro, R., XIVth Meeting of the European Society for Immunodeficiencies, October 6-9, 2010, Istanbul, Turkey (R-26). 2010.
Nydegger, U.E., Immunoglobulins chap 18 (pp 260-272) in Rossi's principles of transfusion medicine 4th edn Edited by T.L. Simon 2009.
Ware, J., Snow, KK, Kosinski M, Gandek B, SF-36 Health Survey: a manual and interpretation guide. Boston, MA. The Heath Institute, New England Medical Centre. 1993.
Cohen, J. Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ : Erlbaum. 1998.

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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT02503293    
Other Study ID Numbers: GAN-06
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases