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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01814800

Public ClinicalTrials.gov record NCT01814800. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 11:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open Label, Multicenter, Study to Evaluate the Pharmacokinetics, Efficacy and Safety of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 Diseases (PIDD).

Study identification

NCT ID
NCT01814800
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
ADMA Biologics, Inc.
Industry
Enrollment
59 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
2 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2014 (Type not available)
Primary completion
Dec 2014 (Actual)
Completion
Jan 2015 (Actual)
Last update posted
Oct 5, 2016

2014 – 2015

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
IMMUNOe Health Centers Cenntennial Colorado 80112 —
Allergy Associates of the Palm Beaches, P.A. North Palm Beach Florida 33408 —
Family Allergy Center, PC Atlanta Georgia 30342 —
The South Bend Clinic, LLP South Bend Indiana 46617 —
Asthma & Immunology Associates Omaha Nebraska 68124 —
Mount Sinai School of Medicine New York New York 10029 —
Dallas Immunology Research Dallas Texas 75230 —
AARA Research Center Dallas Texas 75231 —
Baylor Texas Children's Hospital Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01814800, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 5, 2016 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01814800 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →