ClinicalTrials.gov record
Completed Phase 2Phase 3 Interventional Results available

Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD

ClinicalTrials.gov ID: NCT01485796

Public ClinicalTrials.gov record NCT01485796. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 17, 2026, 4:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Tolerability, Safety and Administration Mode Evaluation of Recombinant Human Hyaluronidase (rHuPH20) Facilitated Subcutaneous Treatment With Immune Globulin Infusion (Human), 10% in Subjects With Primary Immunodeficiency Diseases (PIDD)

Study identification

NCT ID
NCT01485796
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Baxalta now part of Shire
Industry
Enrollment
54 participants

Conditions and interventions

Interventions

  • Immune Globulin Infusion (Human), 10% Biological
  • Recombinant human hyaluronidase Biological

Biological

Eligibility (public fields only)

Age range
2 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 28, 2011
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012
Last update posted
May 18, 2021

2011 – 2013

United States locations

U.S. sites
10
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
University of California, Irvine Irvine California 92697
IMMUNOe International Research Centers Thornton Colorado 80233
Allergy Associates of the Palm Beaches, PA North Palm Beach Florida 33408
LSU Health Sciences Center & Children´s Hospital New Orleans Louisiana 70118
Midwest Immunology Plymouth Minnesota 55446
Midlands Pediatrics PC Papillion Nebraska 68046
Winthrop Allergy and Immunology Mineola New York 11501
Oklahoma Institute of Allergy & Asthma Clinical Research Oklahoma City Oklahoma 73131
Allergy and Clinical Immunology Associates Pittsburgh Pennsylvania 15241
Allergy, Asthma & Immunology Clinic PA Irving Texas 75063

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01485796, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 18, 2021 · Synced May 17, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01485796 live on ClinicalTrials.gov.

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