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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 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)

NCT03093480

CompletedPhase 4

Sponsor: Bioverativ, a Sanofi company

Conditions: Hemophilia A With Inhibitors

Interventions: rFVIIIFc

Countries: United States, Belgium, Bulgaria, Canada, France, Germany, Italy, Japan

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.

Eligibility overview

Sex: MALE

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
Locations (37)
  • Orange, California, United States
  • Aurora, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Detroit, Michigan, United States
  • Dayton, Ohio, United States
  • El Paso, Texas, United States
  • Fort Worth, Texas, United States
  • Houston, Texas, United States
  • Milwaukee, Wisconsin, United States
  • Brussels, Belgium
  • Leuven, Belgium
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Vancouver, British Columbia, Canada
  • Hamilton, Ontario, Canada
  • Toronto, Ontario, Canada
  • Marseille, Bouches-Du-Rhône, France
  • Besançon, Doubs, France
  • Toulouse, Haute Garonne, France
  • Lille, Nord, France
  • Paris, France
  • Bonn, North Rhine-Westphalia, Germany
  • Milan, Italy
  • Naples, Italy
  • Vicenza, Italy
  • Nagoya, Aichi-ken, Japan
  • Kawasaki, Kanagawa, Japan
  • + 7 more on CT.gov