AgammaglobulinemiaPhase 3NCT00168012
Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 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.
Trial summary
The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency. As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied. Read more about this study
- Who is it for?
- Ages 3 to 70 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
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Sep 2005
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with primary immunodeficiency
- Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10
Who cannot join
- Allergic reactions to immunoglobulins or other blood products
- Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day
- History of cardiac insufficiency
- Epilepsia
About this study
Official title: An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)
The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.
As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.
Secondary outcomes (4)
Rate of acute serious bacterial infections
Number of days out of work/school due to underlying PID
Number of infections
Rate, severity and relationship of all adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2004
- Study completionSep 2005
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168012
- Sponsor's protocol ID
- ZLB04_005CR
- Status last verified
- Feb 2011
- First submitted
- 12 Sep 2005
- Last updated
- 11 Feb 2011
- Results posted
- No
Publications
Berger M, Cunningham-Rundles C, Bonilla FA, Melamed I, Bichler J, Zenker O, Ballow M. Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases. J Clin Immunol. 2007 Sep;27(5):503-9. doi: 10.1007/s10875-007-9096-9. Epub 2007 May 4.
PubMed 17479360
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)
- ClinicalTrials.gov ID
- NCT00168012
- Acronym / sponsor ID
- ZLB04_005CR
- Keywords
- Immunoglobulin intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 14 Sep 2005 (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 demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.
As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with primary immunodeficiency
- Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10
Key exclusion criteria (4 listed)
- Allergic reactions to immunoglobulins or other blood products
- Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day
- History of cardiac insufficiency
- Epilepsia
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) | Drug | – |
Primary outcome
Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.
4 secondary outcomes
Rate of acute serious bacterial infections
Number of days out of work/school due to underlying PID
Number of infections
Rate, severity and relationship of all adverse events
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 11 Feb 2011.
- Results publication: PubMed 17479360Berger M, Cunningham-Rundles C, Bonilla FA, Melamed I, Bichler J, Zenker O, Ballow M. Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases. J Clin Immunol. 2007 Sep;27(5):503-9. doi: 10.1007/s10875-007-9096-9. Epub 2007 May 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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.
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 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 11 Feb 2011. 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 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?
Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.. 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 NCT00168012, 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 11 Feb 2011.