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NCT01012323 · ClinicalTrials.gov registry record · Phase 3
A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases
A Phase 3 study of Primary Immunodeficiency Diseases, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
- 7
- Study locations
NCT01012323 is a Phase 3 study of Primary Immunodeficiency Diseases that has completed, run by Octapharma. The registered enrollment target is 51 participants. The trial reports 7 study locations across 7 states.
The verdict
NCT01012323, a Phase 3 study of Primary Immunodeficiency Diseases, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study was to determine the efficacy of NewGam in preventing serious bacterial infections and to determine the pharmacokinetic profile of NewGam. The safety of NewGam and its effect on quality of life were also evaluated.
Conditions Studied
Interventions
- BIOLOGICAL NewGam
Study Locations (7)
California
- Sudir Gupta, MD - Irvine
Colorado
- Isaac Melamed, MD - Centennial
Illinois
- James Moy, MD - Chicago
Indiana
- William Smits, MD - Fort Wayne
Missouri
- Dr. Alan Knutsen - St Louis
Nebraska
- Ai Lan Kobayashi, MD - Papillion
Washington
- Hans Ochs, MD - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01012323
The ClinicalTrials.gov registry entry for NCT01012323 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Octapharma, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Immunodeficiency Diseases appearing as the primary indexed condition, and to 1 intervention - of which NewGam is the first listed.
NCT01012323 reports 7 study locations spanning 7 distinct geographic areas - top geographies include California, Colorado, Illinois.
Frequently Asked Questions
What is clinical trial NCT01012323 about?
NCT01012323 is a clinical study titled "A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases". The purpose of this study was to determine the efficacy of NewGam in preventing serious bacterial infections and to determine the pharmacokinetic profile of NewGam. The safety of NewGam and its effect on quality of life were also evaluated.
What is the current status of trial NCT01012323?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2010-01. Estimated completion is 2012-06.
What conditions does trial NCT01012323 study?
This clinical trial studies the following conditions: Primary Immunodeficiency Diseases.
What interventions are being tested in trial NCT01012323?
The interventions under investigation include: NewGam (BIOLOGICAL).
Who is sponsoring clinical trial NCT01012323?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01012323 being conducted?
This trial has 7 study locations across California, Colorado, Illinois, Indiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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