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Status:

COMPLETED

Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)

Lead Sponsor:

ADMA Biologics, Inc.

Conditions:

Primary Immune Deficiency Disorder

Eligibility:

All Genders

2-75 years

Phase:

PHASE3

Brief Summary

This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Dis...

Detailed Description

Primary immunodeficiency diseases (PIDDs) are genetically determined disorders of the immune system resulting in greatly enhanced susceptibility to infectious disease, autoimmunity and malignancy. As ...

Eligibility Criteria

Inclusion

  • To be eligible to participate in this study, the subjects must meet the following criteria:
  • Signed a written informed consent or a specific assent form for minors.
  • Have a diagnosis of primary immunodeficiency disease.
  • Be ≥ 2 years and ≤ 75 years.
  • Have body weight ≥ 12 kg at screening.
  • Have been receiving IGIV at a dose that has not been changed by \>50% of the mean dose on a mg/kg basis for at least 3 months prior to study entry and have maintained a trough serum Immunoglobulin G (IgG) level ≥ 500 mg/dL on the previous 2 assessments prior to receiving RI 002. The trough level must be at least 300 mg/dL above the pre-treatment serum IgG level.
  • For female subjects, be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant by adherence to a reliable contraceptive method for the duration of the study.

Exclusion

  • Subjects must be excluded if they meet any of the following criteria:
  • Have a known hypersensitivity to immunoglobulin or any excipient in RI-002.
  • Have a history of a severe anaphylactic or anaphylactoid reaction to blood or any blood-derived product.
  • Have a specific Immunoglobulin A (IgA) deficiency, history of allergic reaction to products containing IgA or has demonstrable antibodies to IgA.
  • Have uncompensated hemodynamically significant congenital or other heart disease.
  • Have a medical condition that is known to cause secondary immune deficiency.
  • Have a significant T-cell deficiency or deficiency of granulocyte number or function.
  • Have significant renal impairment or have a history of acute renal failure.
  • Have abnormal liver function.
  • Be receiving chronic anti-coagulation therapy.
  • Have a history of deep vein thrombosis (DVT), thrombotic or thrombo-embolic event, or are at increased risk for thrombotic events.
  • Current daily use of the following medications:
  • corticosteroids (\> 7.5 mg (or equivalent dose on a mg/kg basis) of prednisone equivalent per day for \> 30 days)
  • immunomodulatory drugs
  • immunosuppressive drugs (excluding topical pimecrolimus (Elidel) and tacrolimus (Protopic))
  • Administration of a hyperimmune or specialty high titer immunoglobulin product.
  • Have uncontrollable arterial hypertension.
  • Have a history of hemolysis or positive Coombs test while undergoing treatment with IGIV therapy.
  • Be morbidly obese as indicated by a Body Mass Index (BMI) ≥ 40
  • Have received any blood product (other than Immunoglobulin G) within 3 months prior to screening.
  • Have received any Respiratory Syncytial Virus (RSV) specific products, including palivizumab (Synagis®) within 3 months prior to screening.
  • Have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months.
  • Have any condition or abnormal laboratory assessment judged by the investigator to preclude participation in the study.
  • Are currently pregnant or nursing.
  • Have hepatitis A, B, or C.

Key Trial Info

Start Date :

February 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2015

Estimated Enrollment :

59 Patients enrolled

Trial Details

Trial ID

NCT01814800

Start Date

February 1 2014

End Date

January 1 2015

Last Update

October 5 2016

Active Locations (9)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

1

IMMUNOe Health Centers

Cenntennial, Colorado, United States, 80112

2

Allergy Associates of the Palm Beaches, P.A.

North Palm Beach, Florida, United States, 33408

3

Family Allergy Center, PC

Atlanta, Georgia, United States, 30342

4

The South Bend Clinic, LLP

South Bend, Indiana, United States, 46617