Primary Immunodeficiency (PID)Phase 4NCT02180763
Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps
A Phase 4 study testing Gammanorm in people with Primary Immunodeficiency (PID), run by Octapharma at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immunodeficiency (PID)
- What is being tested?
- Gammanorm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 8 sitesFrance
- Study dates
- Apr 2014to 26 Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient currently participating in another interventional study at the time of inclusion
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Haut-Leveque Hospital
Bordeaux
University Hospital of Caen
Caen
University Hospital of Lille
Lille
Hospital Dupuytren
Limoges
Clinique Mutualiste
Lyon
University Hospital of Reims
Reims
University Hospital of Toulouse
Toulouse
University Hospital of Tours
Tours
About this study
Official title: 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.
- Conditions
- Primary Immunodeficiency (PID)
- Being tested
- Gammanorm
- Keywords
- Primary Immunodeficiency, PID
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GammanormBiological
Sub-Q IgG
| Study group | Role | What they receive |
|---|---|---|
| Gammanorm® 165 mg/mL | Experimental | Not described Receives: Biological: Gammanorm |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startApr 2014
- Primary completion28 Aug 2016
- Study completion26 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Immunodeficiency (PID)Studies of the same condition, open and under way.
- More trials run by OctapharmaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boris Bienvenu, MD, Principal investigator, Universtiy Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180763
- Sponsor's protocol ID
- GAN-03
- Status last verified
- Aug 2018
- First submitted
- 23 Jun 2014
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02180763
- Acronym / sponsor ID
- GAN-03
- Conditions
- Primary Immunodeficiency (PID)
- Keywords
- Primary Immunodeficiency, PID
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- 28 Aug 2016 (actual)
- Study completion
- 26 Aug 2017 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gammanorm® 165 mg/mL | Experimental | Biological: Gammanorm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patient currently participating in another interventional study at the time of inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GammanormSub-Q IgG | Biological | Gammanorm® 165 mg/mL |
Primary outcome
"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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Derived from this study: PubMed 29855752Bienvenu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Bienvenu, MD principal investigator
Universtiy Hospital of Caen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gammanorm in people with Primary Immunodeficiency (PID), run by Octapharma at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Life Quality Index" (LQI) score (factor I: treatment interference) (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.