Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baxalta now part of Shire
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Newborn subjects \<= 6 months of age: diagnosis of severe congenital protein C deficiency, with documented functional protein C level \< 20%. If a genetic diagnosis is not available prior to initiation of Protein C Concentrate treatment, a documented family history of protein C deficiency is required.
Subjects \> 6 months of age: confirmed diagnosis of severe congenital protein C deficiency, i.e., by
a genetic analysis of severe congenital protein C deficiency (i.e., homozygous or double heterozygous) OR
a documented family history of protein C deficiency AND a documented functional protein C level \< 20% while the subject is in an asymptomatic state and not receiving oral anticoagulation therapy
Signed and dated informed consent from either the subject or the subject's legally authorized representative prior to enrollment. Informed consent includes consent for conducting a genetic analysis (if the genetic defect is unknown).
You may not be if
Subjects with a history of allergic reactions to Protein C Concentrate. In the case of allergic reactions occurring at the Protein C Concentrate injection site; exclusion from the study is at the discretion of the investigator but should be reported as an AE regardless of the subject's inclusion in or exclusion from the study.
Participation in any clinical study in which another investigational agent is used within 30 days prior to enrollment or its use is expected at any time for the duration of study participation.
