Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CSL Behring
Age
Any age
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
PTPs:
Males of any age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels \< 1%) and who participated in a previous CSL-sponsored clinical study with rVIII-SingleChain.
Males 0 to \<65 years age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels \< 1%), who have at least 50 EDs to any FVIII product, and who are not currently enrolled in a CSL-sponsored clinical study with rVIII-SingleChain.
PUPs:
Males 0 to \<18 years of who have been diagnosed with severe congenital hemophilia A (FVIII activity levels \< 1%)
No prior exposure to any Factor VIII product (with the exception of short-term use of blood products).
ITI substudy:
PUPs who have developed a confirmed inhibitor to rVIII-SingleChain in the main study.
You may not be if
Known or suspected hypersensitivity to rVIII-SingleChain or to any excipients of rVIII-SingleChain or Chinese hamster ovary (CHO) proteins.
Currently receiving a therapy not permitted during the study.
Serum creatinine \> 2 x upper limit of normal, alanine aminotransferase or aspartate aminotransferase \> 5 x upper limit of normal at Screening (if specified)
Any first-order family (eg, siblings) history of FVIII inhibitors
For PTPs not rolling over directly from a CSL-sponsored clinical study with rVIII-SingleChain: any history of or current FVIII inhibitors
Clareo Health | An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
