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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: Completed Phase 3 study, sponsored by Octapharma.
NCT01888484 is a Phase 3 study that has completed, run by Octapharma. The registered enrollment target is 75 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary efficacy outcome is the rate of SBI (Serious bacterial infections - defined as bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess) per person-year on treatment.
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 |
What the finished NCT01888484 record still lists
NCT01888484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which octanorm 16.5% is the first listed.
NCT01888484 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01888484's enrollment target sits among peer trials
75 1773rd of 2000 higher than 221 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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