Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977283
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-11-29
Brief Title:
HBsAg Declined Patients Follow-up Study
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
An Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Hepatitis B Patients With HBsAg Decline in Past 6 Months
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The goal of this observational study is to prospectively follow chronic hepatitis B patients who had HBsAg decline in the past 12 months prior to screening The main question it aims to answer are
- Describe treatment pattern and its impact on HBsAg loss in hepatitis B patients who had HBsAg decline in past 12 months due to any reason with or without new molecular entities therapy
Participants will be followed up for 36 months after enrollment and may be extended upon expiration according to study objectives
- Describe treatment pattern and its impact on HBsAg loss in hepatitis B patients who had HBsAg decline in past 12 months due to any reason with or without new molecular entities therapy
Participants will be followed up for 36 months after enrollment and may be extended upon expiration according to study objectives
Detailed Description:
This study is a retrospective and prospective follow-up study for participants who had HBsAg decline in past 6 months due to any reason with or without new molecular entities therapy The follow-up period will be 3 years 36 months after enrollment and may be extended upon expiration according to study objectives Patients are treated or untreated based on current clinical practice guidelines and every medical decision and course of treatment will reflect exclusively the decision of the treating physician in a routine clinical situation The conduct of this non-interventional follow-up study and its documentation procedures will not affect the routine treatment of the subjects It is only requested that any medical decisions procedures and data during this study be documented in the electronic case reportrecord form eCRF according to the study protocol as available from routine medical care Diagnostic testing and monitoring procedures are exclusively based on the decision of the treating physician
In general patients with hepatitis B should be monitored at least twice a year every 6 months every 12 weeks during NUC therapy and every 2 to 4 weeks during interferon-α therapy in accordance with clinical needs Table 3-1 and Table 3-2 For patients had HBsAg decline in past 6 months due to new molecular entities therapy The baseline of this follow-up study is the time when NME discontinued within 28 days of the last does of NME or within 2 half-life period of the NME For patients had HBsAg decline in past 6 months without new molecular entities therapy the baseline should be the time of enrolling in the study The time of enrolling in this study may be posterior or equal to baseline which is not necessarily the baseline of this study The visit window period is 28 days for patients with NUC therapy and 7 days for patients with interferon-α therapy Follow-up study visit data can be collected retrospectively if it has been performed before entry of this study
Medical decisions procedures and data before this follow-up study will also be documented if available Participants will be asked to store a certain amount of blood samples in site during study visit for future HBV markers host immunity or other related tests The retained remaining samples from previous tests before this follow-up study may also be used for HBV related exploratory research after patient informed consent
In general patients with hepatitis B should be monitored at least twice a year every 6 months every 12 weeks during NUC therapy and every 2 to 4 weeks during interferon-α therapy in accordance with clinical needs Table 3-1 and Table 3-2 For patients had HBsAg decline in past 6 months due to new molecular entities therapy The baseline of this follow-up study is the time when NME discontinued within 28 days of the last does of NME or within 2 half-life period of the NME For patients had HBsAg decline in past 6 months without new molecular entities therapy the baseline should be the time of enrolling in the study The time of enrolling in this study may be posterior or equal to baseline which is not necessarily the baseline of this study The visit window period is 28 days for patients with NUC therapy and 7 days for patients with interferon-α therapy Follow-up study visit data can be collected retrospectively if it has been performed before entry of this study
Medical decisions procedures and data before this follow-up study will also be documented if available Participants will be asked to store a certain amount of blood samples in site during study visit for future HBV markers host immunity or other related tests The retained remaining samples from previous tests before this follow-up study may also be used for HBV related exploratory research after patient informed consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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