Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525909
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This is a prospective multicentre observational study of Chronic Hepatitis B CHBin different clinical stages We intend to compare the immune status of various types of CHB patients and we propose to establish a staging and grading criteria for the immune exhaustion status of patients with CHB
Detailed Description:
Two groups were included in this study untreated patients who met the staging subgroups according to Chinese Guidelines for the Prevention and Control of Chronic Hepatitis B 2022 edition or HBsAg negativityGroup 1 The another is those who achieved HBV DNA suppression by NAGroup 2 Patients in Group 1 will be followed up once every six months and in group 2 will be followed up once every three months And patients treated or not treated will be followed up in the study The treatment with NA or combined with interferon will be decided by the consensus of doctors and patients This study does not intervene the treatment but will register the clinical indicators We follow up the patients at each follow-up time point record the subjects clinical indicators at each visit and obtained serum and PBMC specimens for further immune study after the consents of the patients
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