Immunologic Deficiency SyndromesPhase 3IGIVNCT00468273
A Clinical Study of Intravenous Immunoglobulin
A Phase 3 study testing Immune Globulin Intravenous (Human) Omr-IgG-am IGIV in people with Immunologic Deficiency Syndromes, run by FFF Enterprises at 10 sites in 2 countries.
Trial summary
The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human) [IGIV], 5% Solution Omr-IgG-am™ in patients with primary immunodeficiency diseases. Read more about this study
- Who is it for?
- Ages 3 to 75 years
- Conditions the study is for
- Immunologic Deficiency Syndromes
- What is being tested?
- Immune Globulin Intravenous (Human) Omr-IgG-am IGIV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Nov 2006to Aug 2009
- 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ages 3 to 75 years and weigh at least 27 kg.
- Confirmed clinical diagnosis of a Primary Immune Deficiency disease including hypogammaglobulinemia, preferably with documented antibody deficiency, or agammaglobulinemia.
- Has been receiving licensed IGIV for at least 3 months prior to this study.
- Trough IgG levels, dose of IGIV, and treatment intervals for the last 2 consecutive licensed IGIV treatments must be documented.
- The subject or legal guardian has signed the informed consent form. If appropriate, the subject has signed a child assent form.
- The subject or legal representative has signed the HIPAA declaration.
Who cannot join
- Subjects with isolated IgG subclass deficiency or specific antibody deficiency without hypogammaglobulinemia will not be eligible.
- The subject has a history of hypersensitivity or persistent or repeated adverse reactions to human immunoglobulin.
- The subject has selective IgA deficiency, history of reaction to products containing IgA, or is known to have antibodies to IgA.
- The subject is currently participating, or has participated within the previous 30 days, in another clinical study of an investigational product or device.
- The subject is pregnant or is nursing. Women of childbearing potential must agree to using a method of contraception.
- The subject has had an acute bacterial infection within 28 days of screening.
Show all 15Show fewer
- The subject is seropositive for any of the following at screening:
- Antibodies to HIV 1\&2
- Antibodies to HCV
- HbsAg
- The subject, at screening, has alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal.
- The subject has severe renal impairment.
- The subject has a history of DVT, thrombotic or thrombic complications of IGIV therapy.
- The subject suffers from any acute or chronic medical condition that, in the opinion of the investigator, may interfere with the conduct of the study.
- The subject has an acquired medical condition known to cause secondary immune deficiency or otherwise increase the subject's risk of infection.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
1st Allergy and Clinical Research Center
Centennial, Colorado, 80112
Rush University Medical Center
Chicago, Illinois, 60612
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Optimed Research, LLC
Columbus, Ohio, 43235
Pediatric Allergy Immunology Associates
Dallas, Texas, 75230
Allergy, Asthma and Immunology Clinic PA
Irving, Texas, 75230
Mattel Children's Hospital of UCLA
Los Angeles, California, 90095-1752
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, 33408
Canada2 sites
University of Toronto
Toronto, Ontario, M4V1R2
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
About this study
Official title: A Clinical Study of Immune Globulin Intravenous (Human) Omr-IgG-am IGIV in Subjects With Primary Immune Deficiency Diseases
The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human) [IGIV], 5% Solution Omr-IgG-am™ in patients with primary immunodeficiency diseases.
Read the detailed description
This is an open label, single-arm, prospective, multi-center, uncontrolled Phase III clinical study to evaluate the efficacy, pharmacokinetics and safety of Omr-IgG-am™ in patients with primary immunodeficiency diseases.
Approximately 50 subjects will be enrolled for 16 Months:
screening- 1 month treatment-12 months follow-up-3 months
Subjects will be infused every 21 to 28 days according to their previous IVIG treatment schedule. Subjects treated every 28 days will receive 13 study IGIV infusions. Subjects treated every 21 days will receive 17 study IGIV infusions.
We will record the incidence of acute infections, especially acute serious bacterial infections, during the year each subjet is on study.
We will record the incidence of adverse events that occur during each infusion and up to 48 hours after each infusion.
At the time the study is explained to the subjects, each investigator will ask all subjects whose body weight is above 37 kg (or greater as defined by local standards) about their willingness to participate in the pharmacokinetic (PK) portion of the study. This will involve 4 additional visits after the 5th or 6th study IGIV infusion in order to draw blood samples for analysis.
- Conditions
- Immunologic Deficiency Syndromes
- Being tested
- Immune Globulin Intravenous (Human) Omr-IgG-am IGIV
- Keywords
- Deficiency Syndromes, Antibody, Antibody Deficiency Syndrome, Bruton's agammaglobulinemia, Common Variable Immune Deficiency, Hyper IgM syndromes
- Medical subject headings
- Immunologic Deficiency Syndromes, Bruton type agammaglobulinemia, Common Variable Immunodeficiency, Hyper-IgM Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin Intravenous (Human) Omr-IgG-am IGIVDrug
IGIV infusions of 300-900 mg/kg every 3 or 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Immune Globulin | Experimental | Subjects with primary humoral immunodeficiency Receives: Drug: Immune Globulin Intravenous (Human) Omr-IgG-am IGIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute serious bacterial infections
Acute serious bacterial infections are defined in The FDA(CBER) Guidance for industry for studies of IGIV to support marketing of IGIV as replacement therapy for primary humoral immunodeficiency (June, 2008).
Measured: one year
Secondary outcomes (10)
The number of hospitalizations and days of hospitalization per subject per year for PID related infections
Measured: during treatment with study drug-1 year
The incidence of infections other than acute serious bacterial infections
Measured: during treatment with study drug-1 year
The number of days lost from work/school/usual activities
Measured: during treatment with study drug-1 year
The number of days of antibiotic therapy (prophylactic and treatment)
Measured: during treatment with study drug-1 year
Pharmacokinetic parameters of IgG subclasses and specific antibodies will be determined in at least 20 patients: AUC0-t, Cmax, Tmax, t1/2, Vd and elimination rate constants.
Measured: after 5th or 6th study infusion
Trough levels of IgG subclasses and specific antibodies will be estimated for each subject in the pharmacokinetic study at defined intervals.
Measured: Months 0, 5, 9, 12
The number of patients whose trough IgG levels fall below the target of 500 mg/dL at any time will be recorded.
Measured: one year
All adverse events that occur during the study regardless of the investigator's assessment of the relationship to the investigational product.
Measured: one year
Laboratory assessments on blood and urine samples including direct antiglobulin (Coomb's) tests.
Measured: one year
Markers of blood borne virus infections at baseline and up to 3 months after the last infusion i.e. HIV (serology), HCV (serology and NAT), HBV (HbsAg).
Measured: Months -1, 14, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startNov 2006
- Primary completionMay 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Immunologic Deficiency SyndromesStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- FFF Enterprises
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Chaim Roifman, MD, Study chair, The Hospital for Sick ChildrenRobert Roberts, MD, Principal investigator, Mattel Children's Hospital of UCLAIsaac R Melamed, MD, Principal investigator, 1st Allergey and Clinical Research CenterJames Moy, MD, Principal investigator, Rush Universitity Medical CentreEyal Grunebaum, MD, Principal investigator, The Hospital for Sick ChildrenGordan L Sussman, MD, Principal investigator, University of TorontoAkhilesh Chouksey, MD, Principal investigator, Rainbow Babies and Children's HospitalMark Stein, MD, Principal investigator, Allergy Associates of the Palm Beaches
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468273
- Sponsor's protocol ID
- GAM-PID-03-US
- Other IDs
- NCT00468273
- Acronym
- IGIV
- Status last verified
- Aug 2014
- First submitted
- 1 May 2007
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ten RM. Primary immunodeficiencies. Mayo Clin Proc. 1998 Sep;73(9):865-72. doi: 10.4065/73.9.865.
PubMed 9737224Bonilla FA, Geha RS. 12. Primary immunodeficiency diseases. J Allergy Clin Immunol. 2003 Feb;111(2 Suppl):S571-81. doi: 10.1067/mai.2003.86.
PubMed 12592303Bonilla FA, Bernstein IL, Khan DA, Ballas ZK, Chinen J, Frank MM, Kobrynski LJ, Levinson AI, Mazer B, Nelson RP Jr, Orange JS, Routes JM, Shearer WT, Sorensen RU; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol. 2005 May;94(5 Suppl 1):S1-63. doi: 10.1016/s1081-1206(10)61142-8. No abstract available.
PubMed 15945566Chapel HM. Consensus on diagnosis and management of primary antibody deficiencies. Consensus Panel for the Diagnosis and Management of Primary Antibody Deficiencies. BMJ. 1994 Feb 26;308(6928):581-5. doi: 10.1136/bmj.308.6928.581. No abstract available.
PubMed 8148684Roifman CM, Levison H, Gelfand EW. High-dose versus low-dose intravenous immunoglobulin in hypogammaglobulinaemia and chronic lung disease. Lancet. 1987 May 9;1(8541):1075-7. doi: 10.1016/s0140-6736(87)90494-6.
PubMed 2883406Eijkhout HW, van Der Meer JW, Kallenberg CG, Weening RS, van Dissel JT, Sanders LA, Strengers PF, Nienhuis H, Schellekens PT; Inter-University Working Party for the Study of Immune Deficiencies. The effect of two different dosages of intravenous immunoglobulin on the incidence of recurrent infections in patients with primary hypogammaglobulinemia. A randomized, double-blind, multicenter crossover trial. Ann Intern Med. 2001 Aug 7;135(3):165-74. doi: 10.7326/0003-4819-135-3-200108070-00008.
PubMed 11487483Roifman CM, Schroeder H, Berger M, Sorensen R, Ballow M, Buckley RH, Gewurz A, Korenblat P, Sussman G, Lemm G. Comparison of the efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency. A randomized double-blind trial. Int Immunopharmacol. 2003 Sep;3(9):1325-33. doi: 10.1016/s1567-5769(03)00134-6.
PubMed 12890430Berger M. A history of immune globulin therapy, from the Harvard crash program to monoclonal antibodies. Curr Allergy Asthma Rep. 2002 Sep;2(5):368-78. doi: 10.1007/s11882-002-0069-z.
PubMed 12165202
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Immune Globulin Intravenous (Human) Omr-IgG-am IGIV in Subjects With Primary Immune Deficiency Diseases
- ClinicalTrials.gov ID
- NCT00468273
- Acronym / sponsor ID
- IGIV / GAM-PID-03-US
- Conditions
- Immunologic Deficiency Syndromes
- Keywords
- Deficiency Syndromes, Antibody, Antibody Deficiency Syndrome, Bruton's agammaglobulinemia, Common Variable Immune Deficiency, Hyper IgM syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- FFF EnterprisesIndustry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Study start
- Nov 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 May 2007 (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 measure the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human) [IGIV], 5% Solution Omr-IgG-am™ in patients with primary immunodeficiency diseases.
Detailed description
This is an open label, single-arm, prospective, multi-center, uncontrolled Phase III clinical study to evaluate the efficacy, pharmacokinetics and safety of Omr-IgG-am™ in patients with primary immunodeficiency diseases.
Approximately 50 subjects will be enrolled for 16 Months:
screening- 1 month treatment-12 months follow-up-3 months
Subjects will be infused every 21 to 28 days according to their previous IVIG treatment schedule. Subjects treated every 28 days will receive 13 study IGIV infusions. Subjects treated every 21 days will receive 17 study IGIV infusions.
We will record the incidence of acute infections, especially acute serious bacterial infections, during the year each subjet is on study.
We will record the incidence of adverse events that occur during each infusion and up to 48 hours after each infusion.
At the time the study is explained to the subjects, each investigator will ask all subjects whose body weight is above 37 kg (or greater as defined by local standards) about their willingness to participate in the pharmacokinetic (PK) portion of the study. This will involve 4 additional visits after the 5th or 6th study IGIV infusion in order to draw blood samples for analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous Immune Globulin | Experimental | Drug: Immune Globulin Intravenous (Human) Omr-IgG-am IGIVSubjects with primary humoral immunodeficiency |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 3 to 75 years and weigh at least 27 kg.
- Confirmed clinical diagnosis of a Primary Immune Deficiency disease including hypogammaglobulinemia, preferably with documented antibody deficiency, or agammaglobulinemia.
- Has been receiving licensed IGIV for at least 3 months prior to this study.
- Trough IgG levels, dose of IGIV, and treatment intervals for the last 2 consecutive licensed IGIV treatments must be documented.
- The subject or legal guardian has signed the informed consent form. If appropriate, the subject has signed a child assent form.
Key exclusion criteria (15 listed)
- Subjects with isolated IgG subclass deficiency or specific antibody deficiency without hypogammaglobulinemia will not be eligible.
- The subject has a history of hypersensitivity or persistent or repeated adverse reactions to human immunoglobulin.
- The subject has selective IgA deficiency, history of reaction to products containing IgA, or is known to have antibodies to IgA.
- The subject is currently participating, or has participated within the previous 30 days, in another clinical study of an investigational product or device.
- The subject is pregnant or is nursing. Women of childbearing potential must agree to using a method of contraception.
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 Intravenous (Human) Omr-IgG-am IGIVIGIV infusions of 300-900 mg/kg every 3 or 4 weeks | Drug | Intravenous Immune Globulin |
Primary outcome
Incidence of acute serious bacterial infections
Time frame: one year
Acute serious bacterial infections are defined in The FDA(CBER) Guidance for industry for studies of IGIV to support marketing of IGIV as replacement therapy for primary humoral immunodeficiency (June, 2008).
10 secondary outcomes
The number of hospitalizations and days of hospitalization per subject per year for PID related infections
Time frame: during treatment with study drug-1 year
The incidence of infections other than acute serious bacterial infections
Time frame: during treatment with study drug-1 year
The number of days lost from work/school/usual activities
Time frame: during treatment with study drug-1 year
The number of days of antibiotic therapy (prophylactic and treatment)
Time frame: during treatment with study drug-1 year
Pharmacokinetic parameters of IgG subclasses and specific antibodies will be determined in at least 20 patients: AUC0-t, Cmax, Tmax, t1/2, Vd and elimination rate constants.
Time frame: after 5th or 6th study infusion
Trough levels of IgG subclasses and specific antibodies will be estimated for each subject in the pharmacokinetic study at defined intervals.
Time frame: Months 0, 5, 9, 12
The number of patients whose trough IgG levels fall below the target of 500 mg/dL at any time will be recorded.
Time frame: one year
All adverse events that occur during the study regardless of the investigator's assessment of the relationship to the investigational product.
Time frame: one year
Laboratory assessments on blood and urine samples including direct antiglobulin (Coomb's) tests.
Time frame: one year
Markers of blood borne virus infections at baseline and up to 3 months after the last infusion i.e. HIV (serology), HCV (serology and NAT), HBV (HbsAg).
Time frame: Months -1, 14, 16
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 Aug 2014.
- Background: PubMed 9737224Ten RM. Primary immunodeficiencies. Mayo Clin Proc. 1998 Sep;73(9):865-72. doi: 10.4065/73.9.865.
- Background: PubMed 12592303Bonilla FA, Geha RS. 12. Primary immunodeficiency diseases. J Allergy Clin Immunol. 2003 Feb;111(2 Suppl):S571-81. doi: 10.1067/mai.2003.86.
- Background: PubMed 15945566Bonilla FA, Bernstein IL, Khan DA, Ballas ZK, Chinen J, Frank MM, Kobrynski LJ, Levinson AI, Mazer B, Nelson RP Jr, Orange JS, Routes JM, Shearer WT, Sorensen RU; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol. 2005 May;94(5 Suppl 1):S1-63. doi: 10.1016/s1081-1206(10)61142-8. No abstract available.
- Background: PubMed 8148684Chapel HM. Consensus on diagnosis and management of primary antibody deficiencies. Consensus Panel for the Diagnosis and Management of Primary Antibody Deficiencies. BMJ. 1994 Feb 26;308(6928):581-5. doi: 10.1136/bmj.308.6928.581. No abstract available.
- Background: PubMed 2883406Roifman CM, Levison H, Gelfand EW. High-dose versus low-dose intravenous immunoglobulin in hypogammaglobulinaemia and chronic lung disease. Lancet. 1987 May 9;1(8541):1075-7. doi: 10.1016/s0140-6736(87)90494-6.
- Background: PubMed 11487483Eijkhout HW, van Der Meer JW, Kallenberg CG, Weening RS, van Dissel JT, Sanders LA, Strengers PF, Nienhuis H, Schellekens PT; Inter-University Working Party for the Study of Immune Deficiencies. The effect of two different dosages of intravenous immunoglobulin on the incidence of recurrent infections in patients with primary hypogammaglobulinemia. A randomized, double-blind, multicenter crossover trial. Ann Intern Med. 2001 Aug 7;135(3):165-74. doi: 10.7326/0003-4819-135-3-200108070-00008.
- Background: PubMed 12890430Roifman CM, Schroeder H, Berger M, Sorensen R, Ballow M, Buckley RH, Gewurz A, Korenblat P, Sussman G, Lemm G. Comparison of the efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency. A randomized double-blind trial. Int Immunopharmacol. 2003 Sep;3(9):1325-33. doi: 10.1016/s1567-5769(03)00134-6.
- Background: PubMed 12165202Berger M. A history of immune globulin therapy, from the Harvard crash program to monoclonal antibodies. Curr Allergy Asthma Rep. 2002 Sep;2(5):368-78. doi: 10.1007/s11882-002-0069-z.
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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.
Chaim Roifman, MD study chair
The Hospital for Sick Children
Robert Roberts, MD principal investigator
Mattel Children's Hospital of UCLA
Isaac R Melamed, MD principal investigator
1st Allergey and Clinical Research Center
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immune Globulin Intravenous (Human) Omr-IgG-am IGIV in people with Immunologic Deficiency Syndromes, run by FFF Enterprises at 10 sites in 2 countries.
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 6 inclusion and 15 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 Aug 2014. 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, Canada. 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?
Incidence of acute serious bacterial infections (time frame: one year). 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 NCT00468273, which also lists 8 linked publications.
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 Aug 2014.