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Completed Phase 3 Interventional Results available

A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases

ClinicalTrials.gov ID: NCT01012323

Public ClinicalTrials.gov record NCT01012323. 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 Jul 22, 2026, 1:19 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

Clinical Study to Evaluate the Efficacy, Pharmacokinetics and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Patients With Primary Immunodeficiency Diseases

Study identification

NCT ID
NCT01012323
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Octapharma
Industry
Enrollment
51 participants

Conditions and interventions

Interventions

  • NewGam 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
Dec 31, 2009
Primary completion
May 31, 2012
Completion
May 31, 2012
Last update posted
Mar 15, 2017

2010 – 2012

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
Sudir Gupta, MD Irvine California
Isaac Melamed, MD Centennial Colorado
James Moy, MD Chicago Illinois
William Smits, MD Fort Wayne Indiana
Dr. Alan Knutsen St Louis Missouri 63104
Ai Lan Kobayashi, MD Papillion Nebraska
Hans Ochs, MD Seattle Washington

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 NCT01012323, 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 15, 2017 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01012323 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →