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Completed Phase 4 Interventional Results available

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)

ClinicalTrials.gov ID: NCT03093480

Public ClinicalTrials.gov record NCT03093480. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 7:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03093480
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Bioverativ, a Sanofi company
Industry
Enrollment
16 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
Not listed
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 8, 2017 (Actual)
Primary completion
May 4, 2020 (Actual)
Completion
Feb 16, 2021 (Actual)
Last update posted
Mar 28, 2022

2017 – 2021

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Center for Inherited Blood Disorders Orange California 92868 —
University of Colorado Hemophilia & Thrombosis Center Aurora Colorado 80045 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
Rush University Medical Center Chicago Illinois 60612 —
Indiana Hemophilia and Thrombosis Center Indianapolis Indiana 46260 —
University of Iowa Children's Hospital Iowa City Iowa 52242 —
Childrens Hospital of Michigan Detroit Michigan 48201 —
Dayton Children's Hospital Dayton Ohio 45404 —
El Paso Children's Hospital El Paso Texas 79905 —
Cook Children's Medical Center Fort Worth Texas 76104 —
Gulf States Hemophilia and Thrombophilia Center Houston Texas 77030 —
Blood Center of Southeast Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03093480, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 28, 2022 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03093480 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →