Primary Immune DeficiencyPhase 3NCT01461018
Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)
A Phase 3 study testing Immune globulin subcutaneous (Human) in people with Primary Immune Deficiency, run by CSL Behring at 9 sites in Japan.
Trial summary
The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR (NCT01458171). Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Primary Immune Deficiency
- What is being tested?
- Immune globulin subcutaneous (Human)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 9 sitesJapan
- Study dates
- Oct 2011to Jul 2014
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who have completed the preceding follow-up study ZLB07_001CR.
- Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years and <20 years of age at the time of obtaining informed consent), according to the competencies of the subject.
Who cannot join
- Pregnancy or nursing mother.
- Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07_001CR.
- Subjects who are planning to donate blood during the study.
- Known or suspected antibodies to the IMP, or to excipients of the IMP.
- Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Study site
Bunkyō City, Tokyo Metropolitan, 113-8519
Study site
Chiba, Chiba Pref., 260-8677
Study site
Fukuoka, Fukuoka, 812-8582
Study site
Gifu, Gifu Pref., 502-8558
Study site
Koshigaya, Saitama Pref., 343-8555
Study site
Moriguchi, Osaka, 570-8507
Study site
Nagoya, Aichi Pref., 466-8560
Study Site
Sapporo, Hokkaido, 060-8648
Study site
Tokorozawa, Saitama Pref., 359-8513
About this study
Official title: A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency
The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR (NCT01458171).
- Conditions
- Primary Immune Deficiency
- Being tested
- Immune globulin subcutaneous (Human)
- Keywords
- Immune globulin subcutaneous, SCIG, 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.
Immune globulin subcutaneous (Human)Biological
Also called Hizentra
IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.
| Study group | Role | What they receive |
|---|---|---|
| IgPro20 | Experimental | Not described Receives: Biological: Immune globulin subcutaneous (Human) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of infection episodes
Measured: Up to 36 months
Secondary outcomes (8)
Number of subjects with adverse events (AEs)
Measured: Up to 36 months
Percentage of subjects with adverse events (AEs)
Measured: Up to 36 months
Rate of AEs per infusion
Measured: Up to 36 months
Annualized rate of clinically documented serious bacterial infections (SBIs)
SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess.
Measured: Up to 36 months
Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections
Measured: Up to 36 months
Number of days of hospitalization due to infections
Measured: Up to 36 months
Duration of use of antibiotics for infection prophylaxis and treatment
Measured: Up to 36 months
Median serum IgG concentration
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune DeficiencyStudies of the same condition, open and under way.
- More trials run by CSL BehringThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yusuke Watanabe, Study director, CSL Behring K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461018
- Sponsor's protocol ID
- IgPro20_3006
- Status last verified
- Nov 2014
- First submitted
- 24 Oct 2011
- Last updated
- 2 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency
- ClinicalTrials.gov ID
- NCT01461018
- Acronym / sponsor ID
- IgPro20_3006
- Conditions
- Primary Immune Deficiency
- Keywords
- Immune globulin subcutaneous, SCIG, Primary immunodeficiency, PID
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Oct 2011 (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 assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR (NCT01458171).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IgPro20 | Experimental | Biological: Immune globulin subcutaneous (Human) |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have completed the preceding follow-up study ZLB07_001CR.
- Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years and <20 years of age at the time of obtaining informed consent), according to the competencies of the subject.
Key exclusion criteria (5 listed)
- Pregnancy or nursing mother.
- Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07_001CR.
- Subjects who are planning to donate blood during the study.
- Known or suspected antibodies to the IMP, or to excipients of the IMP.
- Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.
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 |
|---|---|---|
| Immune globulin subcutaneous (Human)Also: HizentraIgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. | Biological | IgPro20 |
Primary outcome
Annualized rate of infection episodes
Time frame: Up to 36 months
8 secondary outcomes
Number of subjects with adverse events (AEs)
Time frame: Up to 36 months
Percentage of subjects with adverse events (AEs)
Time frame: Up to 36 months
Rate of AEs per infusion
Time frame: Up to 36 months
Annualized rate of clinically documented serious bacterial infections (SBIs)
Time frame: Up to 36 months
Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections
Time frame: Up to 36 months
Number of days of hospitalization due to infections
Time frame: Up to 36 months
Duration of use of antibiotics for infection prophylaxis and treatment
Time frame: Up to 36 months
Median serum IgG concentration
Time frame: Up to 36 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 2 Dec 2014.
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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.
Yusuke Watanabe study director
CSL Behring K.K.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immune globulin subcutaneous (Human) in people with Primary Immune Deficiency, run by CSL Behring at 9 sites in Japan.
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 2 inclusion and 5 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. 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 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 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?
Annualized rate of infection episodes (time frame: Up to 36 months). 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 2 Dec 2014.