Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-02-28 @ 2:11 PM
Study NCT ID:
NCT02947100
Status:
TERMINATED
Last Update Posted:
2020-10-19
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Omega-3 Fatty Acids in Sickle Cell Disease
Sponsor:
Robin E. Miller
Organization:
Study Overview
Official Title:
Phase I/II Safety and Dose Escalation Trial of the Omega-3 Fatty Acids Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) in Children and Young Adults With Sickle Cell Disease (SCD)
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
manufacturing problem with study drug
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety of a new formulation of the omega-3 fatty acids Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) and to assess whether it decreases inflammation and inflammatory pain in children and young adults with Sickle Cell Disease.
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P20GM109021 | NIH | None | https://reporter.nih.gov/quic… | View |