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NCT01485796 · ClinicalTrials.gov registry record · Phase 2
Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD
A Phase 2 study of Primary Immunodeficiency Diseases (PID), sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 10
- Study locations
NCT01485796: Completed Phase 2 study of Primary Immunodeficiency Diseases (PID), sponsored by Baxalta now part of Shire.
NCT01485796 is a Phase 2 study of Primary Immunodeficiency Diseases (PID) that has completed, run by Baxalta now part of Shire. The registered enrollment target is 54 participants, below the 105-participant average among 3 other Primary Immunodeficiency Diseases (PID) trials with a reported enrollment target (49% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01485796, a Phase 2 study of Primary Immunodeficiency Diseases (PID), has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of the study is to acquire additional data on safety and tolerability of recombinant human hyaluronidase (rHuPH20) facilitated subcutaneous treatment of Immune Globulin Infusion (Human), 10% (IGI, 10%) and to assess the mode of product administration. Following a discussion with the FDA at the end of July 2012, all participants still active in the study stopped treatment with rHuPH20 to assure safety of the participants participating in the study and went into a safety follow-up. During this safety follow-up period, participants underwent treatment with the licensed product IGI, 10% (Gammagard Liquid). The intravenous or subcutaneous administration route was at the discretion of the participant and the investigator.
Conditions Studied
Interventions
- BIOLOGICAL Immune Globulin Infusion (Human), 10%
- BIOLOGICAL Recombinant human hyaluronidase
Study Locations (10)
California
- University of California, Irvine - Irvine
Colorado
- IMMUNOe International Research Centers - Thornton
Florida
- Allergy Associates of the Palm Beaches, PA - North Palm Beach
Louisiana
- LSU Health Sciences Center & Children´s Hospital - New Orleans
Minnesota
- Midwest Immunology - Plymouth
Nebraska
- Midlands Pediatrics PC - Papillion
New York
- Winthrop Allergy and Immunology - Mineola
Oklahoma
- Oklahoma Institute of Allergy & Asthma Clinical Research - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2011-12-29 |
| Est. Completion | 2013-01-01 |
| Phase | Phase 2 |
What the finished NCT01485796 record still lists
NCT01485796 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 105-participant average among 3 other Primary Immunodeficiency Diseases (PID) trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Primary Immunodeficiency Diseases (PID) appearing as the primary indexed condition, and to 2 interventions - of which Immune Globulin Infusion (Human), 10% is the first listed.
NCT01485796 lists 10 locations in 10 states (California, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT01485796 about?
NCT01485796 is a clinical study titled "Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD". The purpose of the study is to acquire additional data on safety and tolerability of recombinant human hyaluronidase (rHuPH20) facilitated subcutaneous treatment of Immune Globulin Infusion (Human), 10% (IGI, 10%) and to assess the mode of product administration. Following a discussion with the FDA...
What is the current status of trial NCT01485796?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2011-12-29. Estimated completion is 2013-01-01.
What conditions does trial NCT01485796 study?
This clinical trial studies the following conditions: Primary Immunodeficiency Diseases (PID).
What interventions are being tested in trial NCT01485796?
The interventions under investigation include: Immune Globulin Infusion (Human), 10% (BIOLOGICAL), Recombinant human hyaluronidase (BIOLOGICAL).
Who is sponsoring clinical trial NCT01485796?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01485796 being conducted?
This trial has 10 study locations across California, Colorado, Florida, Louisiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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