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NCT00278954 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.
A Phase 3 study of Hypogammaglobulinemia and Primary Immunodeficiency, sponsored by Bio Products Laboratory.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 7
- Study locations
NCT00278954 is a Phase 3 study of Hypogammaglobulinemia and Primary Immunodeficiency that has completed, run by Bio Products Laboratory. The registered enrollment target is 50 participants, below the 125-participant average among 4 other Hypogammaglobulinemia trials with a reported enrollment target (60% lower). The trial reports 7 study locations across 6 states.
The verdict
NCT00278954, a Phase 3 study of Hypogammaglobulinemia and Primary Immunodeficiency, has completed, sponsored by Bio Products Laboratory.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 7
- Study locations
Study Summary
The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterial infection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID). The secondary objectives are to assess the safety and tolerability of GAMMAPLEX and to determine if GAMMAPLEX has a pharmacokinetic (PK) profile comparable with that of intact Immunoglobulin G (IgG) in subjects with PID.
Conditions Studied
Interventions
- BIOLOGICAL Gammaplex (Intravenous immunoglobulin)
Study Locations (7)
Texas
- Allergy, Asthma & Immunology Clinic, P.A. - Irving
- UCLA Medical Centre - Irving
Florida
- Allergy Associates of the Palm Beaches - North Palm Beach
Georgia
- Family Allergy and Asthma Center PC - Atlanta
Illinois
- Rush University Medical Centre, University Consultants in Allergy & Immunology - Chicago
New York
- Childrens Hospital at Buffalo, Allergy Division - Buffalo
Washington
- University of Washington School of Medicine, Dept. of Pediatrics - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00278954
The ClinicalTrials.gov registry entry for NCT00278954 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 125-participant average among 4 other Hypogammaglobulinemia trials with a reported enrollment target (60% lower). The listed sponsor is Bio Products Laboratory, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Hypogammaglobulinemia appearing as the primary indexed condition, and to 1 intervention - of which Gammaplex (Intravenous immunoglobulin) is the first listed.
NCT00278954 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Texas, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT00278954 about?
NCT00278954 is a clinical study titled "Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.". The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterial infection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID). The secondary objectives ...
What is the current status of trial NCT00278954?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2006-01. Estimated completion is 2007-11.
What conditions does trial NCT00278954 study?
This clinical trial studies the following conditions: Hypogammaglobulinemia, Primary Immunodeficiency, Wiskott-Aldrich Syndrome, Common Variable Hypogammaglobulinemia, X-linked Hypogammaglobulinemia.
What interventions are being tested in trial NCT00278954?
The interventions under investigation include: Gammaplex (Intravenous immunoglobulin) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00278954?
This trial is sponsored by Bio Products Laboratory, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00278954 being conducted?
This trial has 7 study locations across Florida, Georgia, Illinois, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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