NCT06550622Recruiting
Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion
Improved Sensitivity Detection of Serum HBsAg in Chronic Hepatitis B Patients Achieving Functional Cure and Its Association With HBsAg Reversion
Source: ClinicalTrials.gov · Last updated 13 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 8 Aug 2024
- Start date
- 10 Aug 2024
- Primary completion date
- 10 Aug 2027
- Lead sponsor
- Huashan Hospital
- Diseases
- Hepatitis B
- NCT number
- NCT06550622
What you commit to
- Study type: Observational
- Planned participants: 300
- From 10 Aug 2024 to the primary completion date, 10 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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
Other
- Those who are also participating in other clinical studies;
- Patients deemed unsuitable by the investigator to participate in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fahong Li Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.