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:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT04404569
Eligibility Criteria:
Inclusion Criteria:
* Each subject must meet the following criteria:
1. Has participated in and completed all protocol-specified treatments through the required study observation period or time of closure for a prior Bexion-sponsored BXQ-350 clinical study
2. Has completed the End of Study visit of the prior Bexion-sponsored BXQ-350 clinical study
3. Did not meet any treatment discontinuation criteria of the original prior Bexion- sponsored BXQ-350 clinical study
4. Investigator opinion indicates that continued treatment with BXQ-350 is clinically appropriate for the subject
5. Provide signed, written informed consent prior to the initiation of any study-specific procedures (Consent from Guardians for minor children and patient assent according to Institution and Institutional Review Board (IRB) standards)
6. Have a negative serum pregnancy test result within 28 days prior to the first continuing treatment assessment for females of child bearing potential (FCBP); not applicable to subjects who are unable to become pregnant, including those with tubal ligation, bilateral oophorectomy and/or hysterectomy)
7. FCBP and male subjects whose sexual partner(s) are FCBP must agree to abstain from heterosexual activity or use a double barrier method of contraception (e.g., condom and occlusive cap with spermicide) or highly effective contraception (intrauterine device or system, established hormonal contraceptive methods on a stable dose from the time of the last menstrual cycle, or vasectomized partner with confirmed azoospermia) from the time of study entry to 1 month after the last day of treatment
Exclusion Criteria:
* Subjects must not meet any of the following criteria:
1. Has any ongoing adverse event that could impact tolerability to BXQ-350
2. Receiving any other non-BXQ-350 study treatment modalities with curative intent, including investigational products other than BXQ-350
3. Are pregnant or nursing (lactating), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT04404569
Study Brief:
Protocol Section:
NCT04404569