Human-cl-rhFVIII in Previously Untreated Patients

Status: Recruiting
Phase: Phase 3
DFCI Protocol ID:

Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.

Conducting Institutions:

Children's Hospital Boston, Dana-Farber Cancer Institute

Overall PI:

Ellis Neufeld, MD, PhD, Brigham and Women's Hospital

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria:

  -  Male patients

  -  Severe Hemophilia A (FVIII:C <1%)

  -  No previous treatment with with FVIII concentrates or other blood prodcuts containing
     FVIII

Exclusion Criteria:

  -  Diagnosis with a coagulation disorder other than Hemophilia A

  -  Severe liver or kidney disease

  -  Concomitant treatment with any systemic immunosuppressive drug

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