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

April 5, 2019 updated by: Octapharma

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will be followed for a total of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants will be followed for a total of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Octapharma

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2015

Primary Completion (Actual)

December 11, 2017

Study Completion (Actual)

December 11, 2017

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 20, 2015

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAN-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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