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NCT02810444 · ClinicalTrials.gov registry record · Phase 3
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
A Phase 3 study, sponsored by Biotest.
- Completed
- Registry status
- Phase 3
- Development phase
- 81
- Enrollment target
NCT02810444: Completed Phase 3 study, sponsored by Biotest.
NCT02810444 is a Phase 3 study that has completed, run by Biotest. The registered enrollment target is 81 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
NCT02810444, a Phase 3 study, has completed, sponsored by Biotest.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 81 participants
- Enrollment target
Study Summary
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
Primary Outcome
The primary efficacy endpoint was the rate of acute serious bacterial infections, ie, the mean number of acute serious bacterial infections \[SBIs as defined by EMA and FDA\] per subject-year.
Interventions
- BIOLOGICAL IgG Next Generation (BT595)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2016-10-04 |
| Est. Completion | 2020-04-01 |
| Phase | Phase 3 |
What the finished NCT02810444 record still lists
NCT02810444 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 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 IgG Next Generation (BT595) is the first listed.
NCT02810444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02810444 about?
NCT02810444 is a clinical study titled "Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID". This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
What is the current status of trial NCT02810444?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 81 participants. The study started on 2016-10-04. Estimated completion is 2020-04-01.
What interventions are being tested in trial NCT02810444?
The interventions under investigation include: IgG Next Generation (BT595) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02810444?
This trial is sponsored by Biotest, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02810444's enrollment target sits among peer trials
81 1752nd of 2000 higher than 246 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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