An observational study in Primary Immune Deficiencies, Autoimmune Diseases and Inflammatory Diseases, sponsored by O & O Alpan LLC. Status unknown at 1 site in United States. Open to participants aged 1 Day and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-04.
Sponsored by O & O Alpan LLC · Observational
Among 108 studies in Primary Immunodeficiency Diseases with a site in United States — 25 open to participants now, 35 under way, 4 of them phase 3. Primary Immunodeficiency Diseases · United States.
Among the 108 studies in Primary Immunodeficiency Diseases with a site in United States, this one is the 16th largest by enrollment of the 31 observational ones, is one of 2 that started in 2012, is one of 32 observational ones, and was the 43rd registered.
211 studies on the registry are indexed under Primary Immunodeficiency Diseases; 51 are open to participants now.
This study's enrollment of 343 is above the median of 137 across 77 observational studies indexed under Primary Immunodeficiency Diseases.
Browse Primary Immunodeficiency Diseases studies →25 of the 108 studies in Primary Immunodeficiency Diseases with a site in United States are open now, in 3 countries. Each count lists the studies.
Of the 35 Primary Immunodeficiency Diseases studies recruiting now, 12 (34%) set no upper age limit and 10 (29%) stop at 75 or younger; 28 take children under 18; 11 take healthy volunteers.
This study: 1 Day and older · all sexes · healthy volunteers too.
The full table on the hub →108 studies; the count open now beside each. This study's row is marked.
First in 1991; this study’s year is marked. 2 started in 2012.
Median enrollment 40 across the 75 interventional studies, 343 across the 31 observational. Of the 64 that completed or were terminated, 38 (59%) have results posted.
51 of 108 have an industry lead sponsor. The 10 most frequent:
O & O Alpan LLC is the lead sponsor of 7 studies on the registry; none are open to participants now.
O & O Alpan LLC has 1 study filed under Primary Immunodeficiency Diseases — fewer than ten, so there is no comparison to draw.
11 of the studies in Primary Immunodeficiency Diseases with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04640142Phase 3OctapharmaStudy to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases | 2026-11 |
| NCT04944979Phase 3Kedrion S.p.A.Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10) | 2026-12 |
| NCT01962415Paul SzabolcsReduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT | 2026-11 |
| NCT03266627New York Medical CollegeAdenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection | 2026-12-31 |
| NCT03266640New York Medical CollegeVirus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV) | 2026-12-31 |
Among the 108 studies in Primary Immunodeficiency Diseases with a site in United States, from their registry updates:
The immune system is an intricate system comprised of specialized cells, proteins, tissues and organs. Proper functioning is critical to the body's ability to defend itself against harmful pathogens. Immunological disorders and deficiencies are defects in the immune system that lead to abnormal immune responses. Abnormal immune responses could be derived from immune deficiencies, dysregulations or hypersensitivities.
The overall goal of this research study is to identify the mechanisms of primary immune deficiencies and immune disorders at the genetic, cellular and molecular level, using novel analytic techniques to be performed on immune cells derived from blood samples. The knowledge gained from the aims of this study could lead to better diagnostics and identify novel targets for therapeutic interventions.
Primary immunodeficiency diseases (PID) represent a class of disorders in which there is an instrinsic defect in the human immune system. The PID could be caused by defects or perturbations in either the innate or adaptive immune cells, such as B cell defects which result in lack of antibodies. Research in this topic remains a difficult feat due factors such as genetic heterogeneity and the gene-environment interface. Limitations of standard of care testing leads to many patients with immunological problems to be undiagnosed. In addition to the variety of primary immune deficiencies, there are large number of immune system disorders due to various perturbations in the immunological components that cause diseases with much greater prevalence such as autoimmune diseases, lymphoproliferative diseases, chronic inflammation and certain cancers. The causes of these immune disorders are typically more complex than PID but there are also many overlaps in immune hyper-activation and deficiency.
Patients with abnormal immune responses or potential PID or immune disorders (allergies, autoimmune diseases) will be enrolled as the study group and patients with no prior immune abnormalities will be enrolled as the control group.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with abnormal immune responses or potential primary immune deficiencies or immune disorders (allergies, autoimmune diseases) will be enrolled as the study group.
Patients with no prior immune abnormalities will be enrolled as the control group.
Genetic variants
To elucidate genetic variants associated with various previously identified immune disorders to include but not limited to immune dysregulations, hypersensitivities, inflammatory conditions and deficiencies.
Time frame: 10 years
Pathogenesis
To further elucidate pathogenesis of previously discovered immune disorders or subjects with suspected allergic/immunological disorders using cell surface and intracellular staining techniques using flow cytometry.
Time frame: 10 years
The record gives a start of Dec 2012, a primary completion of Dec 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Primary Immunodeficiency Diseases →
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