An observational study in Primary Immunodeficiency, sponsored by IMMUNOe Research Centers. Completed. Open to participants aged 10 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-11-13.
Sponsored by IMMUNOe Research Centers · Observational
Patients with primary immunodeficiency disorders (PID) on intravenous immunoglobulin (IVIG) treatment may experience adverse events (AEs). Patients who experience AEs on any 10% IVIG solution will be changed to octagam 5% for six infusions to evaluate the potential benefit for reduction of AEs on a lower concentration IVIG product.
Patients with PID require life long immunoglobulin (Ig) replacement therapy with IVIG being the most common form. As more 10% IVIG products are FDA approved, the older and well characterized 5% IVIG products are becoming less used. Currently, the standard of care for patients who experience AEs on IVIG is to move to a subcutaneous (SCIG) delivery and product. This study will evaluate the AEs on a 10% product and octagam 5%. The study will enroll 15 patients after an AE on any 10% product who will then be infused with octagam 5% for six infusions. AEs will be documented and compared to the 10% product along with changes in biomarkers. The study data may document another therapeutic option for patients who experience AEs - SCIG and octagam 5%.
211 studies on the registry are indexed under Primary Immunodeficiency Diseases; 51 are open to participants now.
This study's enrollment of 15 is below the median of 137 across 77 observational studies indexed under Primary Immunodeficiency Diseases.
Browse Primary Immunodeficiency Diseases studies →IMMUNOe Research Centers is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of PID - specifically common variable immunodeficiency (CVID)
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The change in the number of AEs post-infusion between any 10% IVIG product and octagam 5%
Time frame: AEs will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks
The change in levels of inflammatory biomarkers associated with AEs between any 10% IVIG and octagam 5%
Time frame: Levels will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks
Safety Evaluations (complete blood count [CBC])
CBC
Time frame: Screening and prior to each infusion (six infusions total) up to 24 weeks
Safety evaluations (Complete Metabolic profile[CMP])
CMP
Time frame: Screening and prior to each infusion (six infusions total) up to 24 weeks
Safety evaluations (IgG trough level)
IgG trough level
Time frame: Screening and prior to last infusion up to 24 weeks
No study locations are listed for this record.
Ran from Jun 2015 to primary completion in Nov 2016, 17 months.
Of 50 observational studies under Primary Immunodeficiency Diseases, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 30. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Primary Immunodeficiency Diseases →
IMMUNOe Research Centers