Trials / Completed
CompletedNCT03093480
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 Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects With Inhibitors Undergoing the First ITI Treatment
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Bioverativ, a Sanofi company · Industry
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rFVIIIFc | rFVIIIFc 200 IU/kg/day in ITI Period, 50 or 100 IU/kg (adjusted according to Investigator judgement) in tapering Period, and prophylactic regimen in Follow-Up period as powder for injection administered intravenously. |
Timeline
- Start date
- 2017-12-08
- Primary completion
- 2020-05-04
- Completion
- 2021-02-16
- First posted
- 2017-03-28
- Last updated
- 2022-03-28
- Results posted
- 2021-07-07
Locations
37 sites across 10 countries: United States, Belgium, Bulgaria, Canada, France, Germany, Italy, Japan, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03093480. Inclusion in this directory is not an endorsement.