Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases
Public ClinicalTrials.gov record NCT01963143. 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, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases
Study identification
- NCT ID
- NCT01963143
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bio Products Laboratory
- Other
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Interventions
- Gammaplex (5%) Biological
- Gammaplex 10 Biological
Biological
Eligibility (public fields only)
- Age range
- 2 Years to 55 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
- Jan 31, 2014
- Primary completion
- Dec 31, 2015
- Completion
- Apr 30, 2016
- Last update posted
- Mar 28, 2017
2014 – 2016
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Allergy Associates | Chandler | Arizona | 85224 | — |
| Miller Children's Hospital | Long Beach | California | 90806 | — |
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | — |
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| IMMUNOe International Research Centers | Centennial | Colorado | 80112 | — |
| Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | — |
| Allergy Associates of the Palm Beaches, PA | North Palm Beach | Florida | 33408 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Institute for Asthma and Allergy | Chevy Chase | Maryland | 20815 | — |
| Asthma and Allergy Center | Toledo | Ohio | 43617 | — |
| Dallas Allergy Immunology Research | Dallas | Texas | 75230 | — |
| University of Utah Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| O&O Alpan, LLC | Fairfax | Virginia | 22030 | — |
| Bellingham Asthma Allergy and Immunology Clinic | Bellingham | Washington | 98225 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01963143, 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 Mar 28, 2017 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01963143 live on ClinicalTrials.gov.