Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases

ClinicalTrials.gov ID: NCT01884311

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.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:18 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

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
Lead sponsor: Bio Products Laboratory; Other
Enrollment: 38 participants

Conditions and interventions

Conditions

Interventions

Subgam Biological

Biological

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 20, 2015 (Actual)
Primary completion: May 25, 2017 (Actual)
Completion: May 25, 2017 (Actual)
Last update posted: Sep 12, 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 12, 2018 · Synced Oct 21, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01884311 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →