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NCT01175213 · ClinicalTrials.gov registry record · Phase 3
Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 66
- Enrollment target
NCT01175213: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT01175213 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 66 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01175213, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 66 participants
- Enrollment target
Study Summary
The original purpose of the study is to assess the long-term safety, tolerability, and practicability of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous Solution (IGSC), 10% facilitated with recombinant human hyaluronidase (rHuPH20) in participants with Primary Immunodeficiency Diseases (PID) who have completed Baxter Clinical Study Protocol No. 160603. Following a discussion with the FDA, all participants still active in the study stopped treatment with rHuPH20 to assure safety of the participants participating in the study and went into a safety follow-up. During this safety follow-up period, participants underwent either intravenous (IV) or SC treatment with IGSC, 10%. The IV or SC administration route was at the discretion of the participant and the investigator.
Primary Outcome
The point estimate of the annual rate of validated acute serious bacterial infections (VASBIs) per participant per year was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20). This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20.
Interventions
- BIOLOGICAL SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety)
- BIOLOGICAL SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety)
- BIOLOGICAL IV treatment with IGSC, 10%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2010-07-28 |
| Est. Completion | 2013-08-06 |
| Phase | Phase 3 |
What the finished NCT01175213 record still lists
NCT01175213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety) is the first listed.
NCT01175213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01175213 about?
NCT01175213 is a clinical study titled "Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID". The original purpose of the study is to assess the long-term safety, tolerability, and practicability of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous Solution (IGSC), 10% facilitated with recombinant human hyaluronidase (rHuPH20) in participants with Primary Immunodeficiency Dis...
What is the current status of trial NCT01175213?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 2010-07-28. Estimated completion is 2013-08-06.
What interventions are being tested in trial NCT01175213?
The interventions under investigation include: SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety) (BIOLOGICAL), SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety) (BIOLOGICAL), IV treatment with IGSC, 10% (BIOLOGICAL).
Who is sponsoring clinical trial NCT01175213?
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 NCT01175213's enrollment target sits among peer trials
66 1797th of 2000 higher than 204 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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