Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT00157118
Eligibility Criteria:
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00157118
Study Brief:
Protocol Section:
NCT00157118