Clareo Health | Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CSL Behring
Age
0–11
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of severe hemophilia A defined as \< 1% Factor VIII (FVIII) concentration (FVIII:C) documented in medical records,
Males \< 12 years of age,
Subjects who have received \> 50 EDs with a FVIII product,
Prior PK data (at least incremental recovery and half-life) from previous FVIII exposure for subjects participating in the PK part
Investigator believes that the subject is willing and able to adhere to all protocol requirements. Investigator believes that the subject's parent(s) or legally acceptable representative(s) is / are willing and able to adhere to all protocol requirements.
You may not be if
Any history of or current FVIII inhibitors
Use of an Investigational Medical Product (IMP) within 30 days prior to the first rVIII-SingleChain administration,
Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to administration of rVIII-SingleChain,
Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein,
Subject currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment,
Subject with serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) values \>5 times (x) the upper limit of normal (ULN) at Screening,
Subjects with serum creatinine values \>2 x ULN at Screening,
Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months before Day 1,
Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months before rVIII-SingleChain administration.
