Primary Immune Deficiency DisorderNCT03037359
A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products
An observational study of Primary Immune Deficiency Disorder, run by ADMA Biologics, Inc. at 17 sites in United States.
Trial summary
This is a safety study to evaluate the risk of low blood pressure in subjects with Primary Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under real world conditions. No study medication will be provided to subjects in this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Immune Deficiency Disorder
- What is being tested?
- Bivigam and Other
- How many people
- 200 participants
- Where
- 17 sitesUnited States
- Study dates
- Dec 2016to 30 Jun 2023
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with primary immunodeficiency disease treated IGIV products.
Who may be able to join
- Patients with PID diagnosis
- Current subjects requiring treatment with an IGIV
Who cannot join
- Patients not meeting inclusion criteria
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Austin Infectious Disease Consultants
Austin, Texas, 78705
Santa Barbara Specialty Pharmacy
Carpinteria, California, 93013
Immunoe Research Centers
Centennial, Colorado, 80112
Allergy Asthma & Immunology Relief
Charlotte, North Carolina, 28204
Discovery Clinical Trials
Dallas, Texas, 75225
Allergy Partners of North Texas
Dallas, Texas, 75230
Allergy Immunology and Respiratory Care
Dallas, Texas, 75231
Lysosomal Rare Disorders Research & Treatment Center
Fairfax, Virginia, 22030
University of Texas Southwestern Medical Center
Irving, Texas, 75390
Central Georgia Infectious Disease Consultants
Macon, Georgia, 31201
Ohio Clinical Research Associates
Mayfield Heights, Ohio, 44124
Midwest Allergy and Sinus
Normal, Illinois, 61761
Oklahoma Institute of Allergy and Asthma Clinical Research
Oklahoma City, Oklahoma, 73131
Kanarek Adult & Pediatric Allergy & Immunology
Overland Park, Kansas, 66211
The Center for Allergy, Asthma & Immunology
Syosset, New York, 11234
Allergy and Asthma of the Bay Area
Walnut Creek, California, 94598
Infectious Disease Consultants
Wichita, Kansas, 67211
About this study
Official title: A Multicenter, Non-interventional, Observational, Prospective Study to Assess Hypotension in Patients With Primary Immunodeficiency Disease Treated With Bivigam™ (Human 10%) or Other Commercial Human 10% Immune Globulin (Intravenous) (IGIV) Products During Infusion and up to 72 Hours Post Infusion
This is a safety study to evaluate the risk of low blood pressure in subjects with Primary Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under real world conditions. No study medication will be provided to subjects in this study. Study physicians will make all treatment decisions according to their usual practice and will provide prescriptions for his/her subjects, as appropriate. The only addition is the collection and structured documentation of data generated through usual practice.
- Conditions
- Primary Immune Deficiency Disorder
- Being tested
- Bivigam, Other
- Keywords
- 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.
BivigamBiological
Human immune globulin
OtherBiological
Human immune globulin
| Study group | Role | What they receive |
|---|---|---|
| Bivigam | Patients with primary immunodeficiency disease treated with Bivigam™ Receives: Biological: Bivigam | |
| Other IGIV | Patients with primary immunodeficiency disease treated with other IGIVs Receives: Biological: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Hypotension
The number of events of hypotension in subjects treated with Bivigam or other immune globulin intravenous (IGIV) products.
Hypotension is defined as a systolic decrease of 30mmHG or a systolic blood pressure less than 90mmHG and clinical symptoms of hypotension including 1 or more of the following: dizziness, light-headedness, fainting (syncope), chest pain, or diaphoresis.
Measured: During infusion and up to 72 hours post infusion.
Secondary outcomes (3)
Rate of Hepatic Impairment
The number of events of hepatic impairment in subjects treated with Bivigam or other immune globulin intravenous products. The criterion for defining hepatic impairment is transaminases three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.
Measured: Throughout the duration of study participation, up to approximately 140 days.
Rate of Renal Impairment
The number of events of renal impairment in subjects treated with Bivigam or other immune globulin intravenous. The criterion for defining hepatic impairment is creatinine values greater than three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.
Measured: Throughout the duration of study participation, up to approximately 140 days.
Rates of Other Adverse Events
The rates of other adverse events in patients treated with Bivigam™ or other immune globulin intravenous products.
Measured: Throughout the duration of study participation, up to approximately 140 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion31 Dec 2022
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Deficiency DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- ADMA Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037359
- Sponsor's protocol ID
- 017
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2017
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-interventional, Observational, Prospective Study to Assess Hypotension in Patients With Primary Immunodeficiency Disease Treated With Bivigam™ (Human 10%) or Other Commercial Human 10% Immune Globulin (Intravenous) (IGIV) Products During Infusion and up to 72 Hours Post Infusion
- ClinicalTrials.gov ID
- NCT03037359
- Acronym / sponsor ID
- 017
- Conditions
- Primary Immune Deficiency Disorder
- Keywords
- PID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ADMA Biologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 31 Jan 2017 (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.
This is a safety study to evaluate the risk of low blood pressure in subjects with Primary Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under real world conditions. No study medication will be provided to subjects in this study. Study physicians will make all treatment decisions according to their usual practice and will provide prescriptions for his/her subjects, as appropriate. The only addition is the collection and structured documentation of data generated through usual practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bivigam | – | Biological: BivigamPatients with primary immunodeficiency disease treated with Bivigam™ |
| Other IGIV | – | Biological: OtherPatients with primary immunodeficiency disease treated with other IGIVs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with primary immunodeficiency disease treated IGIV products.
Key inclusion criteria (2 listed)
- Patients with PID diagnosis
- Current subjects requiring treatment with an IGIV
Key exclusion criteria (1 listed)
- Patients not meeting inclusion criteria
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 |
|---|---|---|
| BivigamHuman immune globulin | Biological | Bivigam |
| OtherHuman immune globulin | Biological | Other IGIV |
Primary outcome
Rate of Hypotension
Time frame: During infusion and up to 72 hours post infusion.
The number of events of hypotension in subjects treated with Bivigam or other immune globulin intravenous (IGIV) products. Hypotension is defined as a systolic decrease of 30mmHG or a systolic blood pressure less than 90mmHG and clinical symptoms of hypotension including 1 or more of the following: dizziness, light-headedness, fainting (syncope), chest pain, or diaphoresis.
3 secondary outcomes
Rate of Hepatic Impairment
Time frame: Throughout the duration of study participation, up to approximately 140 days.
Rate of Renal Impairment
Time frame: Throughout the duration of study participation, up to approximately 140 days.
Rates of Other Adverse Events
Time frame: Throughout the duration of study participation, up to approximately 140 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immune Deficiency Disorder, run by ADMA Biologics, Inc. at 17 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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.
Are results available for this study?
Results are not available in the source record.
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?
Rate of Hypotension (time frame: During infusion and up to 72 hours post infusion.). 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 1 Feb 2023.