Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04667104
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2020-12-09
Brief Title:
A Study of JNJ-73763989 JNJ-56136379 NucleostIde Analogs and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 2 Open-label Single-arm Multicenter Study to Assess Efficacy Safety Tolerability and Pharmacokinetics of Treatment With JNJ-73763989 JNJ-56136379 NucleostIde Analogs and Pegylated Interferon Alpha-2a in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection
Status:
COMPLETED
Status Verified Date:
2024-06
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:
PENGUIN
Brief Summary:
The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen HBsAg levels of the study intervention that is JNJ-73763989 JNJ-56136379 nucleostide analog NA and pegylated interferon alpha-2a PegIFN-alpha2a
Detailed Description:
This study is an intervention specific appendix to the Hepatitis B wings platform trial PLATFORMPAHPB2001 The study title reflects the original study design and JNJ-56136379 JNJ-6379 was initially part of the study intervention but has been removed as part of amendment 3 of the study
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 73763989PAHPB2006 | OTHER | Janssen Research Development LLC | None |
| 2020-003956-34 | EUDRACT_NUMBER | None | None |