Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04535544
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2020-08-28
Brief Title:
A Study of JNJ-73763989 NucleostIde Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-blind Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy Safety and Pharmacokinetics of JNJ-73763989 NucleostIde Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
Status:
ACTIVE_NOT_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:
REEF-D
Brief Summary:
The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus HDV of JNJ-73763989 nucleostide analog NA regimen compared to NA alone
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 |
|---|---|---|---|
| 2020-001249-37 | EUDRACT_NUMBER | None | None |
| 73763989HPB2004 | OTHER | None | None |
| 2023-506763-33-00 | REGISTRY | EUCT number | None |