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NCT01814800 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by ADMA Biologics.

Completed
Registry status
Phase 3
Development phase
59
Enrollment target

NCT01814800 is a Phase 3 study that has completed, run by ADMA Biologics. The registered enrollment target is 59 participants.

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The verdict

NCT01814800, a Phase 3 study, has completed, sponsored by ADMA Biologics.

COMPLETED
Registry status
Phase 3
Development phase
59 participants
Enrollment target

Study 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 Diseases (PIDD).

Interventions

  • BIOLOGICAL RI-002

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2014-02
Est. Completion 2015-01
Phase Phase 3

Sponsor

ADMA Biologics

5 total trials

What the Registry Record Tells You About NCT01814800

The ClinicalTrials.gov registry entry for NCT01814800 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ADMA Biologics, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which RI-002 is the first listed.

NCT01814800 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01814800 about?

NCT01814800 is a clinical study titled "Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)". 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).

What is the current status of trial NCT01814800?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 59 participants. The study started on 2014-02. Estimated completion is 2015-01.

What interventions are being tested in trial NCT01814800?

The interventions under investigation include: RI-002 (BIOLOGICAL).

Who is sponsoring clinical trial NCT01814800?

This trial is sponsored by ADMA Biologics, which has 5 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.