Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps

August 31, 2018 updated by: Octapharma

A Randomized, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL According to the Delivery Device: Injections Using Pump or Rapid Push.

The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

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

  • France
      • Bordeaux, France
        • Haut-levêque Hospital
      • Caen, France
        • University Hospital of Caen
      • Lille, France
        • University Hospital of Lille
      • Limoges, France
        • Hospital Dupuytren
      • Lyon, France
        • Clinique Mutualiste
      • Reims, France
        • University Hospital of Reims
      • Toulouse, France
        • University Hospital of Toulouse
      • Tours, France
        • University Hospital of Tours

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 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
  • Having signed an informed consent form

Exclusion Criteria:

  • Patient currently participating in another interventional study at the time of inclusion

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gammanorm® 165 mg/mL
Biological: Gammanorm
Sub-Q IgG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Life Quality Index" (LQI) score (factor I: treatment interference)
Time Frame: 6 Months
Primary endpoint for assessment of patient's satisfaction regarding the treatment delivery device (pump or syringe) will be the "Life Quality Index" (LQI) score (factor I: treatment interference) at the end of each 3-month treatment period.
6 Months

Collaborators and Investigators

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

Sponsor

Octapharma

Investigators

  • Principal Investigator: Boris Bienvenu, MD, Universtiy Hospital of Caen

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

April 1, 2014

Primary Completion (Actual)

August 28, 2016

Study Completion (Actual)

August 26, 2017

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 3, 2014

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

August 31, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAN-03

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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