Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
Public ClinicalTrials.gov record NCT01884311. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subgam-VF in Primary Immunodeficiency Diseases
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin (IGIV) therapy.
Study identification
- NCT ID
- NCT01884311
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 38 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 75 Years
- 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
- Aug 19, 2015
- Primary completion
- May 24, 2017
- Completion
- May 24, 2017
- Last update posted
- Sep 11, 2018
2015 – 2017
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Allergy Associates | Chandler | Arizona | 85224 | — |
| University of California, Irvine | Irvine | California | 92697 | — |
| University of California San Diego-- Rady's Children's Hospital | San Diego | California | 92123 | — |
| Immunoe International Research | Centennial | Colorado | 80112 | — |
| Allergy Associate of the Palm Beaches | North Palm Beach | Florida | 33408 | — |
| Ann and Robert H Lurie Children's Hospital | Chicago | Illinois | 60611 | — |
| Cardinal Glennon Children's Medical Center | Minneapolis | Minnesota | 63104 | — |
| Optimed Research | Columbus | Ohio | 43235 | — |
| Oklahoma Institute of Allergy & Asthma Clinical Research, LLC | Oklahoma City | Oklahoma | 73131 | — |
| Pennsylvania State University | Hershey | Pennsylvania | 174033 | — |
| Dallas Allergy Immunology | Dallas | Texas | 75230 | — |
| AARA Research Center | Dallas | Texas | 75231 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| O&O Alpan, LLC | Fairfax | Virginia | 22030 | — |
| Bellingham Asthma Allergy Clinic | Bellingham | Washington | 98225 | — |
| The Medical College of Wisconsin/Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 NCT01884311, 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 Sep 11, 2018 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01884311 live on ClinicalTrials.gov.