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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 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 66 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01175213
The ClinicalTrials.gov registry entry for NCT01175213 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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