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)
Completed · Phase 4
Conditions studied: Hemophilia A With Inhibitors
In brief
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.
Key facts
- Study ID
- NCT03093480
- Run by
- Bioverativ, a Sanofi company
- People needed
- 16
- Starts
- 2017-12-08
- Expected to finish
- 2021-02-16
- Last updated by the study team
- 2022-03-28
Who can join
Age: any. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Ability of the participant or his legally authorized representative (e.g., parent or legal guardian) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local participant privacy regulations
- Male participants of any age diagnosed with severe hemophilia A (as confirmed from the medical record)
- Currently diagnosed with high titer inhibitors (historical peak greater than or equal to (>=) 5 Bethesda units per milliliter (BU/mL), according to medical records)
- Previously treated with any plasma-derived or recombinant conventional or Extended Half-Life FVIII
You may not qualify if…
- Other coagulation disorder(s) in addition to hemophilia A
- Previous immune tolerance induction (ITI)
- History of hypersensitivity or anaphylaxis associated with any factor VIII (FVIII) administration
- Planned major surgery scheduled during the study unless deferred until after study completion (minor surgery such as tooth extraction or insertion/replacement of central venous access device is allowed)
- Abnormal renal function (serum creatinine >1.5 milligram per deciliter (mg/dL) or 2 × upper limit of normal (ULN) for participant age based on local laboratory range) as assessed by local laboratory
- Serum alanine aminotransferase or aspartate aminotransferase > 5 × upper limit of normal (ULN) as assessed by local laboratory
Where it is running
- Center for Inherited Blood Disorders — Orange, California, United States
- University of Colorado Hemophilia & Thrombosis Center — Aurora, Colorado, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Indiana Hemophilia and Thrombosis Center — Indianapolis, Indiana, United States
- University of Iowa Children's Hospital — Iowa City, Iowa, United States
- Childrens Hospital of Michigan — Detroit, Michigan, United States
- Dayton Children's Hospital — Dayton, Ohio, United States
- El Paso Children's Hospital — El Paso, Texas, United States
- Cook Children's Medical Center — Fort Worth, Texas, United States
- Gulf States Hemophilia and Thrombophilia Center — Houston, Texas, United States
- Blood Center of Southeast Wisconsin — Milwaukee, Wisconsin, United States
- Cliniques Universitaires Saint-Luc — Brussels, Belgium
- UZ Leuven — Leuven, Belgium
- UMHAT "Sv. Georgi", EAD — Plovdiv, Bulgaria
- UMHAT 'Tsaritsa Yoanna - ISUL', EAD — Sofia, Bulgaria
- Children's & Women's Health Centre of British Columbia — Vancouver, British Columbia, Canada
- McMaster Children's Hospital — Hamilton, Ontario, Canada
- The Hospital for Sick Children — Toronto, Ontario, Canada
- Hôpital de la Timone — Marseille, Bouches-Du-Rhône, France
- CHU Besançon - Hôpital Jean Minjoz — Besançon, Doubs, France
- CHU de Toulouse - Hôpital Purpan — Toulouse, Haute Garonne, France
- Hemostase Clinique - Institut Cœur-Poumons (4eme étage aile est) — Lille, Nord, France
- Hôpital Necker - Enfants Malades — Paris, France
- Universitaetsklinikum Bonn AoeR — Bonn, North Rhine-Westphalia, Germany
Full record on ClinicalTrials.gov
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