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CompletedNCT02180763Updated Sep 5, 2018

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

A Phase 4 interventional study of Gammanorm in Primary Immunodeficiency (PID), sponsored by Octapharma. Completed at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Octapharma · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Primary Immunodeficiency (PID)

Keywords

  • Primary Immunodeficiency, PID
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In context

Primary Immunodeficiency Diseases

199 studies on the registry are indexed under Primary Immunodeficiency Diseases; 46 are open to participants now.

This study's enrollment of 31 is below the median of 37 across 121 interventional studies indexed under Primary Immunodeficiency Diseases.

Browse Primary Immunodeficiency Diseases studies →

Lead sponsor

Octapharma is the lead sponsor of 69 studies on the registry; 8 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patient currently participating in another interventional study at the time of inclusion
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Gammanorm® 165 mg/mL

    Biological: Gammanorm

Interventions

  • BiologicalGammanorm

    Sub-Q IgG

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What researchers measure

Primary outcomes

  1. "Life Quality Index" (LQI) score (factor I: treatment interference)

    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.

    Time frame: 6 Months

07

Study locations

8 sites
  • Haut-Leveque Hospital
    Bordeaux, France
  • University Hospital of Caen
    Caen, France
  • University Hospital of Lille
    Lille, France
  • Hospital Dupuytren
    Limoges, France
  • Clinique Mutualiste
    Lyon, France
  • University Hospital of Reims
    Reims, France
  • University Hospital of Toulouse
    Toulouse, France
  • University Hospital of Tours
    Tours, France
08

References and documents

Publications

  • Bienvenu B, Cozon G, Mataix Y, Lachaud D, Alix A, Hoarau C, Antier D, Hachulla E, Brice S, Viallard JF, Tamisier S, Fauchais AL, Renon-Carron F, Clerson P, Fardini Y, Crave JC, Miossec P. Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients. J Clin Immunol. 2018 May;38(4):503-512. doi: 10.1007/s10875-018-0507-x. Epub 2018 May 31. PubMed 29855752 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02180763
Lead sponsor
Octapharma
Responsible party
Sponsor
First posted
Jul 3, 2014
Start date
Apr 2014
Primary completion
Aug 28, 2016
Completion
Aug 26, 2017
Last update
Sep 5, 2018

Study contacts

Boris Bienvenu, MD
principal investigator · Universtiy Hospital of Caen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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