Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02503293




Registration number
NCT02503293
Ethics application status
Date submitted
1/07/2015
Date registered
20/07/2015
Date last updated
9/04/2019

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
GAN-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Immunodeficiency 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Chrono Super PID then Generic Syringe-Gammanorm
Treatment: Devices - Generic Syringe then Chrono Super PID-Gammanorm

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

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


Treatment: Devices: 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

Treatment: Devices: 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL by delivery device used.
Timepoint [1] 0 0
Participants will be followed for a total of 6 months
Secondary outcome [1] 0 0
To compare the other quality of life scores
Timepoint [1] 0 0
Participants will be followed for a total of 6 months

Eligibility
Key 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.

- 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participating in another interventional clinical study and receiving investigational
medicinal product within three months before study entry.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/12/2017
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CampbelltownHospital - Campbelltown
Recruitment hospital [2] 0 0
Canberra Hospital - Canberra
Recruitment postcode(s) [1] 0 0
NSW 2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
ACT 2605 - Canberra
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Freiburg
Country [2] 0 0
Germany
State/province [2] 0 0
Leipzig
Country [3] 0 0
Italy
State/province [3] 0 0
Padova
Country [4] 0 0
Italy
State/province [4] 0 0
Rome
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Birmingham
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Cardiff
Country [7] 0 0
United Kingdom
State/province [7] 0 0
London
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Oxford
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Octapharma
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02503293
Trial related presentations / publications
Kobrynski L. Subcutaneous immunoglobulin therapy: a new option for patients with primary immunodeficiency diseases. Biologics. 2012;6:277-87. doi: 10.2147/BTT.S25188. Epub 2012 Aug 24.
Gardulf A. Immunoglobulin treatment for primary antibody deficiencies: advantages of the subcutaneous route. BioDrugs. 2007;21(2):105-16. doi: 10.2165/00063030-200721020-00005.
Al-Herz W, Bousfiha A, Casanova JL, Chapel H, Conley ME, Cunningham-Rundles C, Etzioni A, Fischer A, Franco JL, Geha RS, Hammarstrom L, Nonoyama S, Notarangelo LD, Ochs HD, Puck JM, Roifman CM, Seger R, Tang ML. Primary immunodeficiency diseases: an update on the classification from the international union of immunological societies expert committee for primary immunodeficiency. Front Immunol. 2011 Nov 8;2:54. doi: 10.3389/fimmu.2011.00054. eCollection 2011.
Al-Herz W, Bousfiha A, Casanova JL, Chatila T, Conley ME, Cunningham-Rundles C, Etzioni A, Franco JL, Gaspar HB, Holland SM, Klein C, Nonoyama S, Ochs HD, Oksenhendler E, Picard C, Puck JM, Sullivan K, Tang ML. Primary immunodeficiency diseases: an update on the classification from the international union of immunological societies expert committee for primary immunodeficiency. Front Immunol. 2014 Apr 22;5:162. doi: 10.3389/fimmu.2014.00162. eCollection 2014. Erratum In: Front Immunol. 2014;5:460.
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Busse PJ, Razvi S, Cunningham-Rundles C. Efficacy of intravenous immunoglobulin in the prevention of pneumonia in patients with common variable immunodeficiency. J Allergy Clin Immunol. 2002 Jun;109(6):1001-4. doi: 10.1067/mai.2002.124999.
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Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol. 2004 Jul;112(1):1-7. doi: 10.1016/j.clim.2004.02.002.
Church JA, Leibl H, Stein MR, Melamed IR, Rubinstein A, Schneider LC, Wasserman RL, Pavlova BG, Birthistle K, Mancini M, Fritsch S, Patrone L, Moore-Perry K, Ehrlich HJ; US-PID-IGIV 10% -Study Group10. Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency. J Clin Immunol. 2006 Jul;26(4):388-95. doi: 10.1007/s10875-006-9025-3. Epub 2006 May 17.
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Quinti I, Soresina A, Guerra A, Rondelli R, Spadaro G, Agostini C, Milito C, Trombetta AC, Visentini M, Martini H, Plebani A, Fiorilli M; IPINet Investigators. Effectiveness of immunoglobulin replacement therapy on clinical outcome in patients with primary antibody deficiencies: results from a multicenter prospective cohort study. J Clin Immunol. 2011 Jun;31(3):315-22. doi: 10.1007/s10875-011-9511-0. Epub 2011 Mar 2.
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Warnatz, MD
Address 0 0
Centre of Chronic Immunodeficiency, University Medical Centre Freiburg, Breisacher
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02503293