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NCT00157079 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders

A Phase 3 study, sponsored by Baxalta now part of Shire.

Completed
Registry status
Phase 3
Development phase
61
Enrollment target

NCT00157079: Completed Phase 3 study, sponsored by Baxalta now part of Shire.

NCT00157079 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 61 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00157079, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.

COMPLETED
Registry status
Phase 3
Development phase
61 participants
Enrollment target

Study Summary

The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.

Interventions

  • BIOLOGICAL Immune Globulin Intravenous (Human), 10%

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2002-06-25
Est. Completion 2003-12-16
Phase Phase 3
Baxalta now part of Shire

74 total trials

What the finished NCT00157079 record still lists

NCT00157079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Immune Globulin Intravenous (Human), 10% is the first listed.

NCT00157079 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00157079 about?

NCT00157079 is a clinical study titled "Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders". The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.

What is the current status of trial NCT00157079?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2002-06-25. Estimated completion is 2003-12-16.

What interventions are being tested in trial NCT00157079?

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

Who is sponsoring clinical trial NCT00157079?

This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00157079's enrollment target sits among peer trials

61 1803rd of 2000 higher than 197 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00157079, the US trial registry maintained by the National Library of Medicine. NCT00157079 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.