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NCT02895945 · ClinicalTrials.gov registry record · Phase 3
BAX 802 in CHA With Inhibitors
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Terminated
- Registry status
- Phase 3
- Development phase
- 8
- Enrollment target
NCT02895945: Clinical Trial Phase 3 study, sponsored by Baxalta now part of Shire.
NCT02895945 is a Phase 3 study that was terminated before completion, run by Baxalta now part of Shire. The registered enrollment target is 8 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02895945, a Phase 3 study, was terminated before completion, sponsored by Baxalta now part of Shire.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective surgical, dental, or other invasive procedures.
Primary Outcome
GHEA score consisted of 3 individual rating scales: (1) Intra-operative Efficacy Assessment Scale, (2) Post-operative Efficacy Assessment Scale, and (3) Overall Peri-operative Efficacy Assessment Scale. Scales 1 and 2 was performed by the operating surgeon on Day 1, and Scale 3 was performed by the investigator on Day 14. Each rating scale was based on 4 points scale ranging from: 3 (Excellent), 2 (Good), 1 (Fair), and 0 (None). Total score ranged from 0 to 9, where scores evaluated as: excellen
Interventions
- BIOLOGICAL Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-12-22 |
| Est. Completion | 2021-01-22 |
| Phase | Phase 3 |
Why NCT02895945 stopped before completion
NCT02895945 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802) is the first listed.
NCT02895945 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02895945 about?
NCT02895945 is a clinical study titled "BAX 802 in CHA With Inhibitors". The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective surgical, dental, or other invasive procedures.
What is the current status of trial NCT02895945?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 8 participants. The study started on 2016-12-22. Estimated completion is 2021-01-22.
What interventions are being tested in trial NCT02895945?
The interventions under investigation include: Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02895945?
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 NCT02895945's enrollment target sits among peer trials
8 1993rd of 2000 higher than 6 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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