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Clinical Trials/IRCT20101012004920N9
IRCT20101012004920N9
Not Yet Recruiting
Phase 3

Evaluation of Efficacy and Possible Side Effects of Human Polyclonal Antibodies (IVIg) of Medvac Biopharma Co. in the Treatment of Patients with Primary Immunodeficiency disorder (PID)

Medvac BioPharma Company0 sites50 target enrollmentTBD
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ConditionsPrimary immunodeficiency disorder.D84.9 is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes.D84.9

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Primary immunodeficiency disorder.
Sponsor
Medvac BioPharma Company
Enrollment
50
Status
Not Yet Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Medvac BioPharma Company

Eligibility Criteria

Inclusion Criteria

  • •Patients with congenital or primary immunodeficiency of 2\-40years old who weigh 10 kg or more.
  • •Previously confirmed Congenital or Primary Immunodeficiency which have received at least six months of IVIg treatment
  • •Willingness to cooperate and obtain informed written consent from the patient, parent or legal guardian of the child

Exclusion Criteria

  • •Patients with secondary immunodeficiency, newly diagnosed primary immunodeficiency and without treatment, dysglobunemia
  • •History of hypersensitivity to IVIg or other injectable forms of Ig or history of thrombotic complications of IVIg treatment
  • •Patients with IgA deficiency
  • •Concomitant use of corticosteroids, chemotherapy, immunosuppressive drugs
  • •Patients with HIV, hepatitis A, B, C or a history of these diseases
  • •History of severe seizures or migraines
  • •Chronic kidney diseases, liver and various malignancies
  • •Nephrotic syndrome
  • •DVT history
  • •Acute bacterial infection in the last 7 days

Outcomes

Primary Outcomes

Not specified

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