Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965388
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-28
First Post:
2023-06-28
Brief Title:
Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy
Sponsor:
Wen-hong Zhang
Organization:
Huashan Hospital
Study Overview
Official Title:
Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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 prospective exploratory non-intervention multi-center real-world study is to investigate the predictive value of HBV pgRNA in the occurrence of long-term outcomes under antiviral therapy in patients with chronic hepatitis B
Participants will take the necessary clinical examination and blood draw during the patients treatment and follow-up and all the treatment is determined by clinicians
Participants will take the necessary clinical examination and blood draw during the patients treatment and follow-up and all the treatment is determined by clinicians
Detailed Description:
This study is a prospective exploratory multi-center real-world study with Huashan Hospital as the leading unit The study includes patients with chronic hepatitis B who have been determined by clinicians to start or have already taken the first-line treatment including pegylated interferon IFN monotherapy a potent nucleostide analogue NA monotherapy two different potent NAs combination therapy or NA plus IFN combination therapy The study only collects clinical data and serum samples without imposing any additional intervention measures or affecting any relevant clinical decisions The clinical data is collected from the patients clinical follow-up examination data without additional visits and auxiliary examinations Sample collection During the necessary clinical examination and blood draw during the patients treatment and follow-up one additional serum separation tube 3ml was drawn without additional invasive examination for the patient The study will follow up with patients for 5 years to explore the relationship between the serum HBV pgRNA level and the endpoint event at different time points
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?:
False
Is an FDA AA801 Violation?:
None