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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

Primary Purpose

Primary Immunodeficiency

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Chrono Super PID then Generic Syringe-Gammanorm
Generic Syringe then Chrono Super PID-Gammanorm
Sponsored by
Octapharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immunodeficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CampbelltownHospital
  • Canberra Hospital
  • University Medical Centre Freiburg
  • Municipal Hospital "St. Georg"
  • Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica
  • Policlinic Umberto I - Universita di Roma "Sapienza", Clinical Immunology
  • University Hospitals Birmingham
  • University Hospital of Wales
  • - The Royal London Hospital
  • The Royal Free
  • John Radcliff Hospital
  • Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Chrono Super PID then Generic Syringe - Gammanorm

Generic Syringe then Chrono Super PID - Gammanorm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2015
Last Updated
April 5, 2019
Sponsor
Octapharma
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1. Study Identification

Unique Protocol Identification Number
NCT02503293
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 29, 2015 (Actual)
Primary Completion Date
December 11, 2017 (Actual)
Study Completion Date
December 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Octapharma

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immunodeficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chrono Super PID then Generic Syringe - Gammanorm
Arm Type
Other
Arm Description
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
Arm Title
Generic Syringe then Chrono Super PID - Gammanorm
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Chrono Super PID then Generic Syringe-Gammanorm
Other Intervention Name(s)
Automatic Programable compact pump - Chrono Super PID Pump
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Generic Syringe then Chrono Super PID-Gammanorm
Other Intervention Name(s)
Automatic Programable compact pump - Chrono Super PID Pump
Intervention Description
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
Primary Outcome Measure Information:
Title
To compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL by delivery device used.
Description
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.
Time Frame
Participants will be followed for a total of 6 months
Secondary Outcome Measure Information:
Title
To compare the other quality of life scores
Description
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
Time Frame
Participants will be followed for a total of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Warnatz, MD
Organizational Affiliation
Centre of Chronic Immunodeficiency, University Medical Centre Freiburg, Breisacher
Official's Role
Principal Investigator
Facility Information:
Facility Name
CampbelltownHospital
City
Campbelltown
ZIP/Postal Code
NSW 2560
Country
Australia
Facility Name
Canberra Hospital
City
Canberra
ZIP/Postal Code
ACT 2605
Country
Australia
Facility Name
University Medical Centre Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Municipal Hospital "St. Georg"
City
Leipzig
ZIP/Postal Code
D-04129
Country
Germany
Facility Name
Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Policlinic Umberto I - Universita di Roma "Sapienza", Clinical Immunology
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
University Hospitals Birmingham
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF144XW
Country
United Kingdom
Facility Name
- The Royal London Hospital
City
London
ZIP/Postal Code
E12ES
Country
United Kingdom
Facility Name
The Royal Free
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
John Radcliff Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom

12. IPD Sharing Statement

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Learn more about this trial

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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