Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-12 @ 2:14 AM
Study NCT ID:
NCT02018302
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-04-18
First Post:
2013-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Study Continuation of C7 for G1D
Sponsor:
Juan Pascual
Organization:
Study Overview
Official Title:
Post Study Continuation of C7 for G1D
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol provides ongoing access to triheptanoin for patients who did complete an initial pilot protocol, and provides the opportunity to collect long-term safety data from patients treated with triheptanoin.
Detailed Description:
Only patients who completed the initial pilot study were eligible. The study is ongoing with these patients only.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: