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RI-002

Phase 3

Primary Immune Deficiency Disorder | Monoclonal antibody | Immunology |ADMA Biologics Inc|Last Updated: Oct 5, 2016

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment59
FDA Designations
No designations recorded
Clinical trial landscape

RI-002 · 1 trial · 1 indication

Phase 3 1
NCT01814800Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)Primary Immune Deficiency Disorder
COMPLETED59 Analytics
PHASE3COMPLETED
Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
Primary Immune Deficiency Disorder
NCT0181480059
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Study Endpoints
Primary Endpoints
Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008))
One year

The primary objective of this study was to demonstrate that RI-002 (IGIV) reduces the frequency of serious bacterial infections (SBIs), as defined by the Diagnostic Criteria for Serious Infection Types guideline, in subjects with primary humoral immunodeficiency.

Secondary Endpoints
Incidence of All Infections (Serious and Non-serious)
Up to 1 Year
Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Combined Days Lost
Up to 1 year
Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Per Subject-Year
Up to 1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RI-002 TreatmentEXPERIMENTALDrug: RI-002 Dose: 300-800 mg/kg infusion Frequency: Once every 3 to 4 Weeks
Interventions
NameTypeDescription
RI-002BIOLOGICALImmune Globulin Intravenous (IGIV)
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Eligibility Criteria
Age Range2 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: To be eligible to participate in this study, the subjects must meet the following criteria: 1. Signed a written informed consent or a specific assent form for minors. 2. Have a diagnosis of primary immunodeficiency disease. 3. Be ≥ 2 years and ≤ 75 years. 4. Have body weight ≥ ...

Countries:United States
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