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NCT01012323 · ClinicalTrials.gov registry record · Phase 3
A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases
A Phase 3 study of Primary Immunodeficiency Diseases, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
- 7
- Study locations
NCT01012323: Completed Phase 3 study of Primary Immunodeficiency Diseases, sponsored by Octapharma.
NCT01012323 is a Phase 3 study of Primary Immunodeficiency Diseases that has completed, run by Octapharma. The registered enrollment target is 51 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01012323, a Phase 3 study of Primary Immunodeficiency Diseases, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study was to determine the efficacy of NewGam in preventing serious bacterial infections and to determine the pharmacokinetic profile of NewGam. The safety of NewGam and its effect on quality of life were also evaluated.
Primary Outcome
The number of serious bacterial infections per person-year of treatment was calculated by the following formula: Total number of serious bacterial infections / patient-years on NewGam treatment. Serious bacterial infections were defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess.
Conditions Studied
Interventions
- BIOLOGICAL NewGam
Study Locations (7)
California
- Sudir Gupta, MD - Irvine
Colorado
- Isaac Melamed, MD - Centennial
Illinois
- James Moy, MD - Chicago
Indiana
- William Smits, MD - Fort Wayne
Missouri
- Dr. Alan Knutsen - St Louis
Nebraska
- Ai Lan Kobayashi, MD - Papillion
Washington
- Hans Ochs, MD - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT01012323 record still lists
NCT01012323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Primary Immunodeficiency Diseases appearing as the primary indexed condition, and to 1 intervention - of which NewGam is the first listed.
NCT01012323 lists 7 locations in 7 states (California, Colorado, Illinois).
Frequently Asked Questions
What is clinical trial NCT01012323 about?
NCT01012323 is a clinical study titled "A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases". The purpose of this study was to determine the efficacy of NewGam in preventing serious bacterial infections and to determine the pharmacokinetic profile of NewGam. The safety of NewGam and its effect on quality of life were also evaluated.
What is the current status of trial NCT01012323?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2010-01. Estimated completion is 2012-06.
What conditions does trial NCT01012323 study?
This clinical trial studies the following conditions: Primary Immunodeficiency Diseases.
What interventions are being tested in trial NCT01012323?
The interventions under investigation include: NewGam (BIOLOGICAL).
Who is sponsoring clinical trial NCT01012323?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01012323 being conducted?
This trial has 7 study locations across California, Colorado, Illinois, Indiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Immunodeficiency Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01012323's enrollment target sits among peer trials
51 1842nd of 2000 higher than 157 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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