NCT06550622 Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion
| NCT ID | NCT06550622 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huashan Hospital |
| Condition | Hepatitis B, Chronic |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-08-10 |
| Primary Completion | 2027-08-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-08-10 with a primary completion date of 2027-08-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to learn about the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay which has improved sensitivity compared to current ARCHITECT HBsAg Assay. The main question it aims to answer is: What's the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay? HBsAg NEXT assay technology (lower limit of detection for HBsAg is 0.005 IU/ml) and current ARCHITECT HBsAg assay (lower limit of detection for HBsAg is 0.05 IU/ml) are applied for HBsAg detection in patients achieving functional cure, and to compare the difference in HBsAg reversion rate 48 weeks off treatment under the two types of criteria.
Eligibility Criteria
Inclusion Criteria: * HBsAg-negative by Abbott's HBsAg Test and HBeAg-negative; * Having serum specimens retained at baseline and at 48 weeks off treatment follow up; * Being willing to follow up regularly for 1 year. Exclusion Criteria: * Patients with hepatitis B cirrhosis in the compensated and decompensated stages: this includes patients with a clear history of cirrhosis (imaging or histological evidence) or Child-Pugh score ≥5 prior to NUC treatment, or who have had complications of the decompensated stage of cirrhosis, such as ascites, hepatic encephalopathy, or ruptured oesophago-gastric fundal varices bleeding; * Combined HAV, HCV, HDV, HEV, HIV infections, alcoholic liver disease, inherited metabolic liver disease, pharmacological liver disease, non-alcoholic fatty liver disease, autoimmune liver disease and other chronic liver diseases; * Primary hepatocellular carcinoma or those with AFP greater than 100 ng/ml at screening and imaging suggestive of possible malignant hepatic occupancy; or patients with AFP greater than 100 ng/ml for a sustained period of 3 months; * Patients with a combination of other malignant tumours (excluding those who have been cured); * Patients with severe diseases or uncontrolled disease * Those who are also participating in other clinical studies; * Patients deemed unsuitable by the investigator to participate in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06550622 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hepatitis B, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06550622 currently recruiting?
Yes, NCT06550622 is actively recruiting participants. Contact the research team at minelihong@163.com for enrollment information.
Where is the NCT06550622 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06550622 clinical trial?
NCT06550622 is sponsored by Huashan Hospital. The trial plans to enroll 300 participants.