AgammaglobulinemiaPhase 3NCT00322556
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
A Phase 3 study testing Immunoglobulins Intravenous (Human) in people with Agammaglobulinemia and IgG Deficiency, run by CSL Behring at 10 sites in United States.
Trial summary
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes… Read more about this study
- Who is it for?
- Ages 4 to 71 years
- Conditions the study is for
- Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
- What is being tested?
- Immunoglobulins Intravenous (Human)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2005to Apr 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 71 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who:
- Participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)
- OR
- Were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were interested in participating in the Phase III clinical study with subcutaneous IgPro20 (study number ZLB04009CR) (referred to as 'new' subjects)
- Written informed consent
Who cannot join
- Diagnosis of epilepsia
- Insulin dependent diabetes
- Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
- History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Contact CSL Behring for facility details
Centennial, Colorado, 80112
Contact CSL Behring for facility details
Dallas, Texas, 75230
Contact CSL Behring for facility details
Fort Wayne, Indiana, 46815
Contact CSL Behring for facility details
Indianapolis, Indiana, 46202
Contact CSL Behring for facility details
Iowa City, Iowa, 52242
Contact CSL Behring for facility details
Los Angeles, California, 90027
Contact CSL Behring for facility details
North Palm Beach, Florida, 33408
Contact CSL Behring for facility details
Rochester, Minnesota, 55905
Contact CSL Behring for facility details
St Louis, Missouri, 63104-1095
Contact CSL Behring for facility details
St. Petersburg, Florida, 33701
About this study
Official title: A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.
- Being tested
- Immunoglobulins Intravenous (Human)
- Keywords
- Immunoglobulin Intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children
- Medical subject headings
- Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulins Intravenous (Human)Drug
Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw
| Study group | Role | What they receive |
|---|---|---|
| IgPro10 | Experimental | See Intervention Description Receives: Drug: Immunoglobulins Intravenous (Human) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).
AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.
Measured: During each infusion, and within 48 or 72 hours after the end of each infusion.
Influence of Infusion Rate on Temporally-Associated AEs
The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and > 8 and ≤ 12 mg/kg/min).
AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion.
Measured: Within 72 hours after each infusion
Rate of AEs by Severity and Relationship
The AE rate was the number of AEs over the number of infusions administered.
Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities.
At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
Measured: For the duration of the study, up to approximately 29 months
Number of Subjects With Clinically Significant Changes in Vital Signs.
Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
Measured: Before, during, and after each infusion.
Secondary outcomes (5)
Annualized Rate of Acute Serious Bacterial Infections.
The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.
Acute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess.
Measured: For the duration of the study, up to approximately 29 months
Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.
Measured: For the duration of the study, up to approximately 29 months.
Number of Days of Hospitalization.
Measured: For the duration of the study, up to approximately 29 months
Annualized Rate of Any Infection.
The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.
Infections were classified as all AEs with the system organ class "infections and infestations" and AEs with the preferred term "conjunctivitis".
Measured: For the duration of the study, up to approximately 29 months.
Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.
Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed.
Measured: Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startNov 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgammaglobulinemiaStudies 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Program Coordinator, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322556
- Sponsor's protocol ID
- ZLB05_006CR
- Status last verified
- Sep 2012
- First submitted
- 5 May 2006
- Last updated
- 26 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Sleasman JW, Duff CM, Dunaway T, Rojavin MA, Stein MR. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10.
PubMed 20217199
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)
- ClinicalTrials.gov ID
- NCT00322556
- Acronym / sponsor ID
- ZLB05_006CR
- Keywords
- Immunoglobulin Intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 May 2006 (estimated)
- Results
- Posted 26 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IgPro10 | Experimental | Drug: Immunoglobulins Intravenous (Human)See Intervention Description |
Who may qualify
- Ages
- 4 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who:
- Participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)
- OR
- Were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were interested in participating in the Phase III clinical study with subcutaneous IgPro20 (study number ZLB04009CR) (referred to as 'new' subjects)
- Written informed consent
Key exclusion criteria (4 listed)
- Diagnosis of epilepsia
- Insulin dependent diabetes
- Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
- History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension
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 |
|---|---|---|
| Immunoglobulins Intravenous (Human)Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw | Drug | IgPro10 |
Primary outcome
The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).
Time frame: During each infusion, and within 48 or 72 hours after the end of each infusion.
AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.
Influence of Infusion Rate on Temporally-Associated AEs
Time frame: Within 72 hours after each infusion
The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and > 8 and ≤ 12 mg/kg/min). AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion.
Rate of AEs by Severity and Relationship
Time frame: For the duration of the study, up to approximately 29 months
The AE rate was the number of AEs over the number of infusions administered. Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
Number of Subjects With Clinically Significant Changes in Vital Signs.
Time frame: Before, during, and after each infusion.
Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
5 secondary outcomes
Annualized Rate of Acute Serious Bacterial Infections.
Time frame: For the duration of the study, up to approximately 29 months
Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.
Time frame: For the duration of the study, up to approximately 29 months.
Number of Days of Hospitalization.
Time frame: For the duration of the study, up to approximately 29 months
Annualized Rate of Any Infection.
Time frame: For the duration of the study, up to approximately 29 months.
Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.
Time frame: Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20217199Sleasman JW, Duff CM, Dunaway T, Rojavin MA, Stein MR. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10.
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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.
Program Coordinator study director
CSL Behring
10 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 Immunoglobulins Intravenous (Human) in people with Agammaglobulinemia and IgG Deficiency, run by CSL Behring at 10 sites in United States.
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 4 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 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Yes. Results are posted in the registry (first posted 26 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). (time frame: During each infusion, and within 48 or 72 hours after the end of each infusion.). The study lists 4 primary outcomes in all. 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 NCT00322556, 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 26 Oct 2012.