Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 120 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02615691
The ClinicalTrials.gov registry entry for NCT02615691 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PEGylated Recombinant Factor VIII is the first listed.
NCT02615691 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.