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NCT01218438 · ClinicalTrials.gov registry record · Phase 2

Phase 2/3 Study of IGSC, 20% in PIDD

A Phase 2 study, sponsored by Baxalta now part of Shire.

Completed
Registry status
Phase 2
Development phase
86
Enrollment target

NCT01218438 is a Phase 2 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 86 participants.

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The verdict

NCT01218438, a Phase 2 study, has completed, sponsored by Baxalta now part of Shire.

COMPLETED
Registry status
Phase 2
Development phase
86 participants
Enrollment target

Study Summary

The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).

Interventions

  • BIOLOGICAL Immune Globulin Intravenous (Human), 10% Solution
  • DRUG Immune Globulin Subcutaneous (Human), 20% Solution

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2013-01-28
Est. Completion 2015-03-13
Phase Phase 2

Sponsor

Baxalta now part of Shire

74 total trials

What the Registry Record Tells You About NCT01218438

The ClinicalTrials.gov registry entry for NCT01218438 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Immune Globulin Intravenous (Human), 10% Solution is the first listed.

NCT01218438 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01218438 about?

NCT01218438 is a clinical study titled "Phase 2/3 Study of IGSC, 20% in PIDD". The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).

What is the current status of trial NCT01218438?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2013-01-28. Estimated completion is 2015-03-13.

What interventions are being tested in trial NCT01218438?

The interventions under investigation include: Immune Globulin Intravenous (Human), 10% Solution (BIOLOGICAL), Immune Globulin Subcutaneous (Human), 20% Solution (DRUG).

Who is sponsoring clinical trial NCT01218438?

This trial is sponsored by Baxalta now part of Shire, which has 74 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.