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NCT02615691 · ClinicalTrials.gov registry record · Phase 3
A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
NCT02615691: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT02615691 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 120 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02615691, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
Study Summary
This study is for young children with severe hemophilia A who have previously not been treated with BAX855 or other FVIII concentrates. The main aim of the study is to check for side effects from treatment with BAX855. This includes the buildup of antibodies against FVIII which may stop BAX855 from working properly. Another aim is to learn how well BAX855 controls bleeding. In this study, the children can receive BAX855 either as preventative treatment (prophylaxis), or as needed to treat bleeding (on-demand). In case a participant develops antibodies, treatment will be provided as part of the study.
Primary Outcome
Number of participants who developed an inhibitor (at any time) confirmed by a central laboratory based on a second repeat blood sample draw within 2 weeks of site notification of an inhibitor and all participants who had not developed an inhibitor and had greater than or equal to (\>=) 100 EDs when the sample for the last valid inhibitor test was drawn.
Interventions
- BIOLOGICAL PEGylated Recombinant Factor VIII
- BIOLOGICAL ITI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2015-11-12 |
| Est. Completion | 2024-10-29 |
| Phase | Phase 3 |
What the finished NCT02615691 record still lists
NCT02615691 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which PEGylated Recombinant Factor VIII is the first listed.
NCT02615691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02615691 about?
NCT02615691 is a clinical study titled "A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A". This study is for young children with severe hemophilia A who have previously not been treated with BAX855 or other FVIII concentrates. The main aim of the study is to check for side effects from treatment with BAX855. This includes the buildup of antibodies against FVIII which may stop BAX855 from...
What is the current status of trial NCT02615691?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2015-11-12. Estimated completion is 2024-10-29.
What interventions are being tested in trial NCT02615691?
The interventions under investigation include: PEGylated Recombinant Factor VIII (BIOLOGICAL), ITI (BIOLOGICAL).
Who is sponsoring clinical trial NCT02615691?
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 NCT02615691's enrollment target sits among peer trials
120 1619th of 2000 higher than 361 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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