Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-29 @ 2:47 AM
Study NCT ID:
NCT04404569
Status:
TERMINATED
Last Update Posted:
2024-12-20
First Post:
2020-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continued Treatment for Participants Enrolled in Studies of BXQ-350
Sponsor:
Bexion Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
An Open-Label, Multi-Center, Rollover Study to Provide Continued Treatment Access for Participants Enrolled in Studies of BXQ-350
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Bexion Pharmaceuticals no longer has open studies in which subjects would be eligible to rollover and continue treatment under the BXQ-350.AE protocol. Therefore, no additional subjects will be enrolled in this trial.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETERNITI
Brief Summary:
This is a study to allow continued treatment for participants enrolled in studies of BXQ-350. This study is intended only for those who have completed the required study observation period or are still on treatment upon the closure of their respective BXQ-350 clinical study. The additional treatment is optional and voluntary.
Detailed Description:
This is an open-label, multi-center, rollover study to allow continued treatment access for participants enrolled in studies of BXQ-350. This study is intended for subjects who have completed the required study observation period or are still on treatment upon the closure of their respective BXQ-350 clinical study, and who are judged by the Investigator to benefit from continued treatment with BXQ-350. The additional treatment is optional and voluntary.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: