Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627608
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Treatment Prioritisation and Cost-Effectiveness Analysis for HBV Cure - Real-World Evidence from a Territory-Wide Cohort
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Treatment Prioritisation and Cost-Effectiveness Analysis for HBV Cure - Real-World Evidence from a Territory-Wide Cohort
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
A number of hepatitis B virus HBV cure regimens including antisense oligonucleotide ASO and small interfering RNA siRNA are under vigorous clinical development and the efficacy and safety will soon be available for regulatory approval Patients most in need should be prioritised to receive HBV cure regimen to maximise its clinical benefits and speed up hepatitis elimination
Detailed Description:
A territory-wide cohort study of all patients with chronic hepatitis B who have achieved functional cure of HBV Real-world data will be used to estimate the risk of HCC hepatic decompensation and liver-related death for the subsequent simulation of HCC risk in particular populations of patients who achieved HBV cure Literature search also be performed in parallel to cross-validate the estimates in untreated patients and treated patients with incomplete or complete viral suppression with different stages of fibrosis based on existing literature An optional systematic review and meta-analysis may be performed the address these issues
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None