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NCT01888484 · ClinicalTrials.gov registry record · Phase 3
Study of Octanorm Subcutaneous IG in Patients With PID
A Phase 3 study, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
NCT01888484 is a Phase 3 study that has completed, run by Octapharma. The registered enrollment target is 75 participants.
The verdict
NCT01888484, a Phase 3 study, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a 12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm in preventing serious bacterial infections (SBI) compared with historical control data and to evaluate the pharmacokinetic (PK) characteristics of octanorm.
Interventions
- BIOLOGICAL octanorm 16.5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2014-03 |
| Est. Completion | 2020-06-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01888484
The ClinicalTrials.gov registry entry for NCT01888484 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Octapharma, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which octanorm 16.5% is the first listed.
NCT01888484 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01888484 about?
NCT01888484 is a clinical study titled "Study of Octanorm Subcutaneous IG in Patients With PID". This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a 12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm in preventing serious bacterial infections (SBI) compared with historical control data and to evaluate the pharmacok...
What is the current status of trial NCT01888484?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2014-03. Estimated completion is 2020-06-09.
What interventions are being tested in trial NCT01888484?
The interventions under investigation include: octanorm 16.5% (BIOLOGICAL).
Who is sponsoring clinical trial NCT01888484?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
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