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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT03544060
Eligibility Criteria:
Inclusion Criteria:
* Patients who participated in the APPROACH Open Label trial, must have completed the open label extension trial for volanesorsen for a length of time consistent with the study protocol (≥ 1 year). Patients in the APPROACH open Label trial for less than a year require approval from Akcea to participate in the EAP. Patients who did not participate in the APPROACH open label trial require approval from Akcea for entry into EAP.
* Patients not participating in the APPROACH open label trial must have a diagnosis of FCS as determined by the participating physician, as outlined in the Volanesorsen EAP protocol. Akcea will review each application to determine eligibility.
* Male patients and female patients of childbearing potential must continue to use appropriate contraception with their partners, or refrain from sexual activity
Exclusion Criteria:
* Patients who have any new conditions or worsening of existing conditions which in the opinion of the Physician would make the patient unsuitable for treatment with volanesorsen.
* Volanesorsen naïve patients with baseline platelet values ≤ 140,000/mm3
* Patients not willing to adhere to mandatory blood draws for platelet monitoring
* Patients who in the opinion of Akcea's medical team, are not eligible candidates for volanesorsen therapy.
* Any patient who plans to or becomes pregnant.
* Any patient who was withdrawn from the APPROACH open label study due to a serious adverse event related to volanesorsen therapy.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03544060
Study Brief:
Protocol Section:
NCT03544060