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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02503293
Other study ID # GAN-06
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 29, 2015
Est. completion date December 11, 2017

Study information

Verified date April 2019
Source Octapharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 11, 2017
Est. primary completion date December 11, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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
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

Locations

Country Name City State
Australia CampbelltownHospital Campbelltown
Australia Canberra Hospital Canberra
Germany University Medical Centre Freiburg Freiburg
Germany Municipal Hospital "St. Georg" Leipzig
Italy Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica Padova
Italy Policlinic Umberto I - Universita di Roma "Sapienza", Clinical Immunology Rome
United Kingdom University Hospitals Birmingham Birmingham
United Kingdom University Hospital of Wales Cardiff
United Kingdom - The Royal London Hospital London
United Kingdom The Royal Free London
United Kingdom John Radcliff Hospital Oxford
United Kingdom Derriford Hospital Plymouth

Sponsors (1)

Lead Sponsor Collaborator
Octapharma

Countries where clinical trial is conducted

Australia,  Germany,  Italy,  United Kingdom, 

References & Publications (69)

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Gardulf A, Nicolay U, Asensio O, Bernatowska E, Böck A, Carvalho BC, Granert C, Haag S, Hernández D, Kiessling P, Kus J, Pons J, Niehues T, Schmidt S, Schulze I, Borte M. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study. J Clin Immunol. 2006 Mar;26(2):177-85. Epub 2006 Apr 26. — View Citation

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* Note: There are 69 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary To compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL by delivery device used. 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. Participants will be followed for a total of 6 months
Secondary To compare the other quality of life scores 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
Participants will be followed for a total of 6 months
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