Primary ImmunodeficiencyPhase 4NCT02881437
IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia
A Phase 4 study testing IgHy10 in people with Primary Immunodeficiency, run by University Hospital, Lille at 7 sites in France.
Trial summary
Most immunodeficiencies are related to severe immunoglobulin deficiencies which require lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and severity of infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immunodeficiency
- What is being tested?
- IgHy10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 7 sitesFrance
- Study dates
- 11 Nov 2016to Nov 2018
- 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
- Male or female subject at least 18 years old at the time inclusion.
- Suffering from PI requiring immunoglobulin replacement therapy.
- Treated with SCIG at stable dose for at least 3 months at the time of inclusion.
- Well balanced SCIG treatment according to the investigator at the time of inclusion.
- If female of childbearing potential, the subject must have a negative blood or urine pregnancy test at the time of inclusion and must agree to employ adequate birth control measures during the whole study.
- Willing and able to comply with the requirements of the protocol.
- Having signed the informed consent form.
Who cannot join
- Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60 mL/min/1.73m2 estimated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the time of screening.
- Having received a chemotherapy or immunomodulating therapy for either malignant or chronic inflammatory disease for over 6 months.
- Receiving anticoagulant therapy.
- Having abnormal protein loss (protein losing enteropathy, nephrotic syndrome).
- Know allergy to hyaluronidase.
- Family member or employee of the investigator.
Show all 9Show fewer
- Having participated in another interventional clinical study involving an investigational product (IP) or investigational device within 30 days prior to inclusion or scheduled to participate in another clinical study involving an another investigational product or investigational device during the course of this study.
- If female, pregnant or breastfeeding at the time of enrolment.
- If female, planning to become pregnant during the time period of the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHRU, Hôpital Claude Huriez
Lille
Hôpital de la Conception
Marseille, 13005
CHU de Nantes - Hôtel Dieu
Nantes, 44093
Hôpital St Louis
Paris, 75010
Hôpital Necker
Paris, 75015
Hôpital Haut Lévèque
Pessac, 33604
CHU de Strasbourg
Strasbourg, 67000
About this study
Official title: Assessment of the IgG Trough Level in Subjects With Primary Immunodeficiency Switching From Standard Subcutaneous Immunoglobulin (SCIG) to Every Other Week HyQvia
Most immunodeficiencies are related to severe immunoglobulin deficiencies which require lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and severity of infections. IgG can be administered intravenously (IGIV) every 21 or 28 days or subcutaneously every week or every other week (IGSC) for subjects who do not tolerate IV infusions or have difficulties with venous access. No head-to-head data are available to directly compare HyQvia with conventional SCIG. However, SCIG is indicated for administration frequencies from daily up to every other week dosing while HyQvia is indicated for infusion frequencies every 2-4 weeks. This study is designed to assess the IgG trough level after switching from standard SCIG to every other week HyQvia and HyQvia every 3-4 weeks
Read the detailed description
Open-label, one arm study conducted in France in subjects with PI to IgG trough level at steady state after standard SCIG dosing and after HyQvia administered every other week and every 3-4 weeks at equivalent dose. The study will have three periods:
- The first period is a one-week ramp-up period. The first administration of HyQvia will be with a one-week dose as specified in the summary of product characteristics of HyQvia.
- During the first three-month follow-up period, HyQvia will be administered, every other week at a dose equivalent to the dose administered with the previous treatment (standard SCIG).
- At the end of this first follow-up period, the dose of HyQvia will be increased for the next infusion to reach a 3-week equivalent dose. If it this volume is well tolerated, the following dosing will be a 4-week equivalent dose. HyQvia will then be administered every 3 or 4 weeks for three months.
- Conditions
- Primary Immunodeficiency
- Being tested
- IgHy10
- Keywords
- Primary Immunodeficiency, SubCutaneous Immunoglobulins
- 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.
IgHy10Drug
Also called HyQvia
Sub Cutaneous IgHy10 administration
| Study group | Role | What they receive |
|---|---|---|
| IgHy10 (HyQvia) | Experimental | Open-label, one arm study conducted in France in subjects with PI to IgG trough level at steady state after standard SCIG dosing and after IgHy10 (HyQvia) administered every other week and every 3-4 weeks at equivalent dose. The study will have three periods:
* The first period is a one-week ramp-up period. The first administration of IgHy10 (HyQvia) will be with a one-week dose
* During the first three-month follow-up period, IgHy10 (HyQvia) will be administered, every other week at a dose equivalent to the dose administered with the previous treatment (standard SCIG).
* At the end of this first follow-up period, the dose of IgHy10 (HyQvia) will be increased for the next infusion to reach a 3-4 week equivalent dose. Receives: Drug: IgHy10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change in IgG trough level at 3 months (visit 3) as compared to baseline (visit 1).
Measured: Every 2 weeks during the baseline (visit 1) and the 3 months (visit3)
Secondary outcomes (6)
The change in IgG trough level at 6 months (visit 4) as compared to baseline (visit 1) and 3 months (visit 3).
Measured: Every 3 weeks after the 3 months (visit 3) as 6 months ( visit 4)
Number of adverse reactions
Measured: 6 months
Incidence rate of adverse reactions
Measured: 6 months
Number of infection
Measured: 6 months
The Short Form (36) Health Survey
standardized test for measuring the quality of life
Measured: at 6 months
Treatment Satisfaction Questionnaire for Medication (TSQM-9).
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start11 Nov 2016
- Primary completion16 Mar 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary ImmunodeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Sponsor
- Investigators
- Eric Hachulla, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881437
- Sponsor's protocol ID
- 2015_31
- Other IDs
- 2016-001480-36, 2016
- Status last verified
- Jun 2019
- First submitted
- 17 Aug 2016
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the IgG Trough Level in Subjects With Primary Immunodeficiency Switching From Standard Subcutaneous Immunoglobulin (SCIG) to Every Other Week HyQvia
- ClinicalTrials.gov ID
- NCT02881437
- Acronym / sponsor ID
- 2015_31
- Conditions
- Primary Immunodeficiency
- Keywords
- Primary Immunodeficiency, SubCutaneous Immunoglobulins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Shire
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 16 Mar 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 29 Aug 2016 (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.
Most immunodeficiencies are related to severe immunoglobulin deficiencies which require lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and severity of infections. IgG can be administered intravenously (IGIV) every 21 or 28 days or subcutaneously every week or every other week (IGSC) for subjects who do not tolerate IV infusions or have difficulties with venous access. No head-to-head data are available to directly compare HyQvia with conventional SCIG. However, SCIG is indicated for administration frequencies from daily up to every other week dosing while HyQvia is indicated for infusion frequencies every 2-4 weeks. This study is designed to assess the IgG trough level after switching from standard SCIG to every other week HyQvia and HyQvia every 3-4 weeks
Detailed description
Open-label, one arm study conducted in France in subjects with PI to IgG trough level at steady state after standard SCIG dosing and after HyQvia administered every other week and every 3-4 weeks at equivalent dose. The study will have three periods:
- The first period is a one-week ramp-up period. The first administration of HyQvia will be with a one-week dose as specified in the summary of product characteristics of HyQvia.
- During the first three-month follow-up period, HyQvia will be administered, every other week at a dose equivalent to the dose administered with the previous treatment (standard SCIG).
- At the end of this first follow-up period, the dose of HyQvia will be increased for the next infusion to reach a 3-week equivalent dose. If it this volume is well tolerated, the following dosing will be a 4-week equivalent dose. HyQvia will then be administered every 3 or 4 weeks for three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IgHy10 (HyQvia) | Experimental | Drug: IgHy10Open-label, one arm study conducted in France in subjects with PI to IgG trough level at steady state after standard SCIG dosing and after IgHy10 (HyQvia) administered every other week and every 3-4 weeks at equivalent dose. The study will have three periods: * The first period is a one-week ramp-up period. The first administration of IgHy10 (HyQvia) will be with a one-week dose * During the first three-month follow-up period, IgHy10 (HyQvia) will be administered, every other week at a dose equivalent to the dose administered with the previous treatment (standard SCIG). * At the end of this first follow-up period, the dose of IgHy10 (HyQvia) will be increased for the next infusion to reach a 3-4 week equivalent dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subject at least 18 years old at the time inclusion.
- Suffering from PI requiring immunoglobulin replacement therapy.
- Treated with SCIG at stable dose for at least 3 months at the time of inclusion.
- Well balanced SCIG treatment according to the investigator at the time of inclusion.
- If female of childbearing potential, the subject must have a negative blood or urine pregnancy test at the time of inclusion and must agree to employ adequate birth control measures during the whole study.
Key exclusion criteria (9 listed)
- Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60 mL/min/1.73m2 estimated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the time of screening.
- Having received a chemotherapy or immunomodulating therapy for either malignant or chronic inflammatory disease for over 6 months.
- Receiving anticoagulant therapy.
- Having abnormal protein loss (protein losing enteropathy, nephrotic syndrome).
- Know allergy to hyaluronidase.
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 |
|---|---|---|
| IgHy10Also: HyQviaSub Cutaneous IgHy10 administration | Drug | IgHy10 (HyQvia) |
Primary outcome
The primary endpoint is the change in IgG trough level at 3 months (visit 3) as compared to baseline (visit 1).
Time frame: Every 2 weeks during the baseline (visit 1) and the 3 months (visit3)
6 secondary outcomes
The change in IgG trough level at 6 months (visit 4) as compared to baseline (visit 1) and 3 months (visit 3).
Time frame: Every 3 weeks after the 3 months (visit 3) as 6 months ( visit 4)
Number of adverse reactions
Time frame: 6 months
Incidence rate of adverse reactions
Time frame: 6 months
Number of infection
Time frame: 6 months
The Short Form (36) Health Survey
Time frame: at 6 months
Treatment Satisfaction Questionnaire for Medication (TSQM-9).
Time frame: at 6 months
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 25 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Eric Hachulla, MD, PhD principal investigator
University Hospital, Lille
7 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 IgHy10 in people with Primary Immunodeficiency, run by University Hospital, Lille at 7 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 7 inclusion and 9 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 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The primary endpoint is the change in IgG trough level at 3 months (visit 3) as compared to baseline (visit 1). (time frame: Every 2 weeks during the baseline (visit 1) and the 3 months (visit3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2019.