Primary Immunodeficiency Diseases (PID)Phase 3NCT00157079
Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders
A Phase 3 study testing Immune Globulin Intravenous (Human), 10% in people with Primary Immunodeficiency Diseases (PID) and Immune Thrombocytopenic Purpura (ITP), run by Baxalta now part of Shire at 11 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders. Read more about this study
- Who is it for?
- Ages 24 months and older
- Conditions the study is for
- Primary Immunodeficiency Diseases (PID), Immune Thrombocytopenic Purpura (ITP), Kawasaki Syndrome
- What is being tested?
- Immune Globulin Intravenous (Human), 10%
- Type of treatment
- Injection or infusion
- How many people
- 61 participants
- Where
- 11 sitesUnited States
- Study dates
- 25 Jun 2002to 16 Dec 2003
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration
- Diagnosis of a PID disorder as defined by World Health Organization criteria for which the subject has been receiving a regimen of IGIV infusions every 21 to 28 days over a period of at least 4 months pre-study at a dose of 300-600 mg/kg body weight
- Subjects > 24 months of age
- A negative serum pregnancy test for any female subject who is of childbearing potential.
Who cannot join
- Subjects sero-positive at enrollment for one or more of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (HCV), antibodies to human immunodeficiency virus (HIV) Types 1 or 2
- Subjects with levels of alanine amino transferase (ALT) and aspartate amino transferase (AST) > 2.5 times the upper limit of normal for the testing laboratory. An AST > 2.5 times the upper limit of normal is allowable, if the ALT does not exceed the upper limit of the reference range for the testing laboratory
- Subjects with neutropenia (defined as an ANC >= 1,000/mm3)
- Subjects with serum creatinine levels greater than two times the upper limit of normal for age and gender
- Subjects with malignancy or a history of malignancy
- Subjects who received any blood or blood product exposure other than an IGIV and/or immune serum globulin (ISG) preparation within the 6 months prior to study entry
Show all 12Show fewer
- Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV and/or ISG infusions
- Subjects with selective complete IgA deficiency
- Subjects with moderate levels of anti-IgA antibodies (>150), or subjects with lower anti-IgA antibodies who are naive to IGIV treatment. (Subjects with lower levels of IgA antibodies, whom the investigators know to have tolerated IgA containing IGIV preparations in the past, may be included if the investigator is comfortable with this)
- Subjects receiving antibiotic therapy for the treatment of infection within 30 days prior to enrollment
- Subjects who receive prophylactic antibiotics as part of their care regimen
- Subjects participating in another clinical study involving an investigational product or device within 30 days prior to study entry
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Children´s Hospital Boston
Boston, Massachusetts, 02115
Rush Presbyterian - St. Lukes Medical Center
Chicago, Illinois, 60612
Pediatric Allergy/Immunology Associates
Dallas, Texas, 75230
1st Allergy and Clinical Research Center
Englewood, Colorado, 80112
Children´s Hospital Los Angeles
Los Angeles, California, 90027
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, 33408
Allergy, Asthma & Immunology Assoc.
Omaha, Nebraska, 68124
Asthma and Allergy Center
Papillion, Nebraska, 68046
Stanford University Medical Center
Stanford, California, 94304-8786
University of South Florida; Asthma, Allergy & Immunology CRU
Tampa, Florida, 33613
Montefiore Medical Center, Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: A Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders
The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.
- Conditions
- Primary Immunodeficiency Diseases (PID), Immune Thrombocytopenic Purpura (ITP), Kawasaki Syndrome
- Being tested
- Immune Globulin Intravenous (Human), 10%
- Keywords
- PID, Immunodeficiency, Immune Thrombocytopenic Purpura (ITP), Kawasaki syndrome
- Medical subject headings
- Primary Immunodeficiency Diseases, Purpura, Thrombocytopenic, Idiopathic, Mucocutaneous Lymph Node Syndrome, Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin Intravenous (Human), 10%Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of acute serious bacterial infections per participant per year
Measured: Throughout the study period of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study start25 Jun 2002
- Primary completion16 Dec 2003
- Study completion16 Dec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency Diseases (PID)Studies 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
- Randomised
- Intervention model
- Crossover
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157079
- Sponsor's protocol ID
- 160101
- Status last verified
- Aug 2021
- First submitted
- 8 Sep 2005
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders
- ClinicalTrials.gov ID
- NCT00157079
- Acronym / sponsor ID
- 160101
- Conditions
- Primary Immunodeficiency Diseases (PID), Immune Thrombocytopenic Purpura (ITP), Kawasaki Syndrome
- Keywords
- PID, Immunodeficiency, Immune Thrombocytopenic Purpura (ITP), Kawasaki syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2002 (actual)
- Primary completion
- 16 Dec 2003 (actual)
- Study completion
- 16 Dec 2003 (actual)
- First posted
- 12 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 assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
Who may qualify
- Ages
- 24 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration
- Diagnosis of a PID disorder as defined by World Health Organization criteria for which the subject has been receiving a regimen of IGIV infusions every 21 to 28 days over a period of at least 4 months pre-study at a dose of 300-600 mg/kg body weight
- Subjects > 24 months of age
- A negative serum pregnancy test for any female subject who is of childbearing potential.
Key exclusion criteria (12 listed)
- Subjects sero-positive at enrollment for one or more of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (HCV), antibodies to human immunodeficiency virus (HIV) Types 1 or 2
- Subjects with levels of alanine amino transferase (ALT) and aspartate amino transferase (AST) > 2.5 times the upper limit of normal for the testing laboratory. An AST > 2.5 times the upper limit of normal is allowable, if the ALT does not exceed the upper limit of the reference range for the testing laboratory
- Subjects with neutropenia (defined as an ANC >= 1,000/mm3)
- Subjects with serum creatinine levels greater than two times the upper limit of normal for age and gender
- Subjects with malignancy or a history of malignancy
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), 10% | Biological | – |
Primary outcome
Mean number of acute serious bacterial infections per participant per year
Time frame: Throughout the study period of 18 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 24 Aug 2021.
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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.
Study Director study director
Takeda
11 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 Intravenous (Human), 10% in people with Primary Immunodeficiency Diseases (PID) and Immune Thrombocytopenic Purpura (ITP), run by Baxalta now part of Shire at 11 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 4 inclusion and 12 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 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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?
Mean number of acute serious bacterial infections per participant per year (time frame: Throughout the study period of 18 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 24 Aug 2021.