High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)
Public ClinicalTrials.gov record NCT01313507. 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
Clinical Study to Evaluate the Safety and Tolerability of Immunoglobulin Intravenous (Human) 10% (NewGam) Administered at High Infusion Rates to Patients With Primary Immunodeficiency Diseases (Extension of Study NGAM-01)
Study identification
- NCT ID
- NCT01313507
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Octapharma
- Industry
- Enrollment
- 21 participants
Conditions and interventions
Conditions
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
- Apr 30, 2011
- Primary completion
- Aug 31, 2012
- Completion
- Aug 31, 2012
- Last update posted
- Mar 28, 2017
2011 – 2012
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Irvine | Irvine | California | — | — |
| Immunoe Research Center | Centennial | Colorado | — | — |
| Rush Universtity Medical Center | Chicago | Illinois | — | — |
| Cardinal Glennon Children's Hospital | St Louis | Missouri | — | — |
| Midlands Pediatrics | Papillion | Nebraska | — | — |
| Seattle Children's Hospital | 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 NCT01313507, 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 Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01313507 live on ClinicalTrials.gov.