Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421636
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-14
Brief Title:
A Study to Test the Safety Tolerability and Efficacy of an Antibody REGN7999 Injected Under the Skin for the Treatment of Iron Overload in Adult Participants With Non-Transfusion Dependent β-thalassemia Using MRI Scans to Measure Iron Levels in the Body
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A PHASE 2 TWO-PART RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER STUDY TO EVALUATE THE EFFICACY SAFETY AND TOLERABILITY OF SUBCUTANEOUSLY ADMINISTERED REGN7999 AN INHIBITOR OF TMPRSS6 IN PARTICIPANTS WITH IRON OVERLOAD DUE TO NON-TRANSFUSION DEPENDENT β-THALASSEMIA
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FERVENT-1
Brief Summary:
This study is researching an experimental drug called REGN7999 called study drug The study is focused on patients with non-transfusion dependent beta-thalassemia The aim of the study is to see how safe and effective the study drug is
The study is looking at several other research questions including
Whether the study drug lowers extra iron levels in the body
What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
The study is looking at several other research questions including
Whether the study drug lowers extra iron levels in the body
What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508604-37-00 | OTHER | EU CT Number | None |