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NCT00782106 · ClinicalTrials.gov registry record · Phase 1
Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously
A Phase 1 study of Primary Immunodeficiency Diseases (PID), sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 3
- Study locations
NCT00782106 is a Phase 1 study of Primary Immunodeficiency Diseases (PID) that has completed, run by Baxalta now part of Shire. The registered enrollment target is 11 participants, below the 119-participant average among 3 other Primary Immunodeficiency Diseases (PID) trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT00782106, a Phase 1 study of Primary Immunodeficiency Diseases (PID), has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of the study is to determine the feasibility of infusing a full 4-week dose of Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of recombinant human hyaluronidase needed to infuse that dose with no more than mild local adverse drug reactions.
Conditions Studied
Interventions
- BIOLOGICAL Recombinant human hyaluronidase + immune globulin intravenous
Study Locations (3)
Colorado
- First Allergy and Clinical Research Center - Centennial
Florida
- Allergy Associates of the Palm Beaches - North Palm Beach
Texas
- Pediatrics Allergy/Immunology Association, PA - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-12-04 |
| Est. Completion | 2007-11-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00782106
The ClinicalTrials.gov registry entry for NCT00782106 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 119-participant average among 3 other Primary Immunodeficiency Diseases (PID) trials with a reported enrollment target (91% lower). The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Immunodeficiency Diseases (PID) appearing as the primary indexed condition, and to 1 intervention - of which Recombinant human hyaluronidase + immune globulin intravenous is the first listed.
NCT00782106 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Colorado, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT00782106 about?
NCT00782106 is a clinical study titled "Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously". The purpose of the study is to determine the feasibility of infusing a full 4-week dose of Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of recombinant human hyaluronidase needed to infuse that dose with no more than mild local adverse drug reactions.
What is the current status of trial NCT00782106?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2006-12-04. Estimated completion is 2007-11-01.
What conditions does trial NCT00782106 study?
This clinical trial studies the following conditions: Primary Immunodeficiency Diseases (PID).
What interventions are being tested in trial NCT00782106?
The interventions under investigation include: Recombinant human hyaluronidase + immune globulin intravenous (BIOLOGICAL).
Who is sponsoring clinical trial NCT00782106?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00782106 being conducted?
This trial has 3 study locations across Colorado, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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