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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT01461018
Eligibility Criteria:
Inclusion Criteria:
* Subjects who have completed the preceding follow-up study ZLB07\_001CR.
* Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years and \<20 years of age at the time of obtaining informed consent), according to the competencies of the subject.
Exclusion Criteria:
* Pregnancy or nursing mother.
* Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07\_001CR.
* Subjects who are planning to donate blood during the study.
* Known or suspected antibodies to the IMP, or to excipients of the IMP.
* Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT01461018
Study Brief:
Protocol Section:
NCT01461018