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NCT03093480 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)
A Phase 4 study, sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT03093480: Completed Phase 4 study, sponsored by Bioverativ, a Sanofi company.
NCT03093480 is a Phase 4 study that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03093480, a Phase 4 study, has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
The primary purpose of this study was to describe the time to tolerization (i.e., ITI success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI treatment.
Primary Outcome
Time required for participants to achieve immune tolerance induction (ITI) success where ITI success is defined as achieving all 3 of the following criteria: confirmed negative titers consisting of 2 consecutive negative inhibitor assessments within 2 weeks (less than \[\<\] 0.6 Bethesda units/milliliter \[mL\] by the Nijmegen-modified Bethesda assay); incremental recovery (IR) greater than or equal to (\>=) 66 percent (%) of the expected IR in 2 consecutive assessments; half-life (t½) \>= 7 hou
Interventions
- BIOLOGICAL rFVIIIFc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-12-08 |
| Est. Completion | 2021-02-16 |
| Phase | Phase 4 |
What the finished NCT03093480 record still lists
NCT03093480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which rFVIIIFc is the first listed.
NCT03093480 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03093480 about?
NCT03093480 is a clinical study titled "A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)". The primary purpose of this study was to describe the time to tolerization (i.e., ITI success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI treatment.
What is the current status of trial NCT03093480?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2017-12-08. Estimated completion is 2021-02-16.
What interventions are being tested in trial NCT03093480?
The interventions under investigation include: rFVIIIFc (BIOLOGICAL).
Who is sponsoring clinical trial NCT03093480?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03093480's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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