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A Multicenter, Open-label, Prospective Cohort Study: The Potential Role of Serum HBV RNA Quantification in Optimizing Clinical Cure strategy in Chronic Hepatitis B Patients treaated with Nucleoside (Analogue) Analogues

Clinical value of HBV RNA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014904
Enrollment
Unknown
Registered
2018-02-14
Start date
2018-02-11
Completion date
Unknown
Last updated
2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis B

Interventions

HBeAg positive :no

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 60 years old; 2. liver function compensated (no history of ascites, hepatic encephalopathy or upper gastrointestinal bleeding); 3. pregnancy test of childbearing age women is negative; 4. HBeAg positive CHB before NAs treatment: NAs treatment= 12 months, HBV DNA was undetected=12 months (Roche diagnostic reagent kit was selected for screening, the lower limit of detection of HBV DNA was 20 IU/ml), HBeAg seroconversion had occurred =6 months, HBsAg <1500IU/ml, and ALT=1.5ULN; 5. HBeAg-negative CHB before initional of NAs treatment: NAs treatment=12 months, HBV DNA was undetected=12(Roche diagnostic reagent kit was selected for screening, the lower limit of detection of HBV DNA was 20 IU/m), HBsAg<1500 IU/ml and ALT=1.5 ULN; 6. fundus oculi examination was normal; 7. previously used interferon-alpha (Interferon-alpha, IFN-alpha) or PegIFN-alpha, the use of the last dose of interferon should be within a distance of 6 months or more; 8. obtain the informed consent of the subjects.

Exclusion criteria

Exclusion criteria: 1. The telbivudine was included in the NAs antiviral regimen at enrollment; 2. Interleukin and its components are allergic; 3. neutrophils 50ng/mL; or a history of suspected malignancy or malignancy over the past 5 years; 8. mental illness, uncontrollable epilepsy; 9. subjects receiving corticosteroid, immunosuppressive, and chemotherapeutic drugs within 6 months prior to enrollment; 10. Women with pregnancy, lactation and pregnancy planning during the study; 11. ultrasound or CT imaging examination indicated cirrhosis, or suggested any one of the following: LSM=12.0 kPa, or aspartate aminotransferase and platelet ratio index (APRI )> 2 points, or liver biopsy pathology in the most recent 1 year is indicative of cirrhosis; 12. receiving trial medication within the last 3 months; 13. serum total bilirubin> 2.0 ×ULN; 14. poor compliance; 15. researcher believe there are other conditions that may not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
HBV RNA;

Secondary

MeasureTime frame
Hepatic histopathology;

Countries

China

Contacts

Public ContactSujun Zheng

Beijing Youan Hospital, Capital Medical University

zhengsujun003@126.com+86 15810716239

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026