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Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD
NCT01485796 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01485796
The ClinicalTrials.gov registry entry for NCT01485796 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01485796 reports 10 study locations spanning 10 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01485796?
The interventions under investigation include: Immune Globulin Infusion (Human), 10% (BIOLOGICAL), Recombinant human hyaluronidase (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01485796?
This trial is sponsored by Baxalta now part of Shire, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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