Primary Immune Deficiency DisorderPhase 3NCT03492710
Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency
A Phase 3 study testing Immunoglobulin in people with Primary Immune Deficiency Disorder, run by Green Cross Corporation.
Trial summary
To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID) Read more about this study
- Who is it for?
- Ages 24 to 203 months
- Conditions the study is for
- Primary Immune Deficiency Disorder
- What is being tested?
- Immunoglobulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2019to 30 Apr 2019
- Phase
- Phase 3
- 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 24 to 203 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia
- Subject is willing to comply with all requirements of protocol
- Authorization to access personal health information
Who cannot join
- Subject has secondary immunodeficiency
- Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG
- Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia
About this study
Official title: Phase III Study of Immune Globulin Intravenous (Human) IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency
To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)
- Conditions
- Primary Immune Deficiency Disorder
- Being tested
- Immunoglobulin
- 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.
ImmunoglobulinBiological
Also called IGIV-SN
Administer volume of IGIV-SN to maintain a trough level of of 5g/L or more
| Study group | Role | What they receive |
|---|---|---|
| IGIV-SN | Experimental | Immunoglobulin, Supplied in 5g (100mL) and/or 10g (200mL) Receives: Biological: Immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections)
The incidence of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess
Measured: 13 months (12 months of treatment + 1 month of Follow-Up)
Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug
The overall incidence of adverse events (AEs) that occur during or within 1 hours, 24 hours, and 72 hours following an infusion of test product, regardless of whether or not the AE is determined to be product related
Measured: 13 months (12 months of treatment + 1 month of Follow-Up)
Secondary outcomes (2)
Efficacy: Incidence of Infections other than acute serious bacterial infections
Measured: 13 months (12 months of treatment + 1 month of Follow-Up)
Safety: The frequency of all AEs that occuring during the study
(regardless of the casual relationship)
Measured: 13 months (12 months of treatment + 1 month of Follow-Up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start30 Apr 2019
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Why it stopped: A change in sponsor's developmental strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Deficiency DisorderStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chaim Roifman, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492710
- Sponsor's protocol ID
- GC5101F
- Status last verified
- Jul 2020
- First submitted
- 19 Feb 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Immune Globulin Intravenous (Human) IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency
- ClinicalTrials.gov ID
- NCT03492710
- Acronym / sponsor ID
- GC5101F
- Conditions
- Primary Immune Deficiency Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A change in sponsor's developmental strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 10 Apr 2018 (actual)
- 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.
To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter
| Arm | Type | Receives |
|---|---|---|
| IGIV-SN | Experimental | Biological: ImmunoglobulinImmunoglobulin, Supplied in 5g (100mL) and/or 10g (200mL) |
Who may qualify
- Ages
- 24 to 203 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia
- Subject is willing to comply with all requirements of protocol
- Authorization to access personal health information
Key exclusion criteria (3 listed)
- Subject has secondary immunodeficiency
- Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG
- Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia
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 |
|---|---|---|
| ImmunoglobulinAlso: IGIV-SNAdminister volume of IGIV-SN to maintain a trough level of of 5g/L or more | Biological | IGIV-SN |
Primary outcome
Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections)
Time frame: 13 months (12 months of treatment + 1 month of Follow-Up)
The incidence of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess
Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug
Time frame: 13 months (12 months of treatment + 1 month of Follow-Up)
The overall incidence of adverse events (AEs) that occur during or within 1 hours, 24 hours, and 72 hours following an infusion of test product, regardless of whether or not the AE is determined to be product related
2 secondary outcomes
Efficacy: Incidence of Infections other than acute serious bacterial infections
Time frame: 13 months (12 months of treatment + 1 month of Follow-Up)
Safety: The frequency of all AEs that occuring during the study
Time frame: 13 months (12 months of treatment + 1 month of Follow-Up)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
Related trials for Primary Immune Deficiency Disorder
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
RecruitingObservational study
Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES)
Infections, Pneumonia
RecruitingObservational study
Genetic Basis of Immunodeficiency
Severe Combined Immunodeficiency
RecruitingObservational study
Detection and Characterization of Infections and Infection Susceptibility
Immune Deficiencies
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.
Chaim Roifman principal investigator
The Hospital for Sick Children
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunoglobulin in people with Primary Immune Deficiency Disorder, run by Green Cross Corporation.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections) (time frame: 13 months (12 months of treatment + 1 month of Follow-Up)). The study lists 2 primary outcomes in all. 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 7 Jul 2020.