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NCT00814320 · ClinicalTrials.gov registry record · Phase 3
Gammagard Liquid and rHuPH20 in PID
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 89
- Enrollment target
NCT00814320: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT00814320 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 89 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00814320, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 89 participants
- Enrollment target
Study Summary
The purpose of the study is to develop a subcutaneous treatment option for participants with Primary Immunodeficiency Diseases (PID) that allows an administration of Immune Globulin Intravenous (Human), 10% at the same frequency as IV administration.
Primary Outcome
Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen. VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only. The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calcula
Interventions
- BIOLOGICAL Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2008-12-18 |
| Est. Completion | 2010-11-11 |
| Phase | Phase 3 |
What the finished NCT00814320 record still lists
NCT00814320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV) is the first listed.
NCT00814320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00814320 about?
NCT00814320 is a clinical study titled "Gammagard Liquid and rHuPH20 in PID". The purpose of the study is to develop a subcutaneous treatment option for participants with Primary Immunodeficiency Diseases (PID) that allows an administration of Immune Globulin Intravenous (Human), 10% at the same frequency as IV administration.
What is the current status of trial NCT00814320?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2008-12-18. Estimated completion is 2010-11-11.
What interventions are being tested in trial NCT00814320?
The interventions under investigation include: Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00814320?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00814320's enrollment target sits among peer trials
89 1738th of 2000 higher than 262 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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