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A predictive study on the failure to achieve pathological reversal and stable clinical compensation in patients with hepatitis B related cirrhosis after 2 ~ 3 years of antiviral therapy

A predictive study on the failure to achieve pathological reversal and stable clinical compensation in patients with hepatitis B related cirrhosis after 2 ~ 3 years of antiviral therapy

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000037352
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

Hepatitis B related cirrhosis

Interventions

Gold Standard:Pathological diagnosis
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model&#32
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no&#32
reversal&#32
or&#32
unstable&#32
compensation&#32
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cirrhosis

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The design of this study belongs to the retrospective and ambispective cohort study. This study included two groups of patients: Patients in Group I come from the retrospective cohort and in Group II come from the ambispective cohort. The ambispective cohort will be created by this study. 1. Inclusion criteria for patients in Group I: HBsAg positive chronic hepatitis; pathological diagnosis of liver cirrhosis had been made after more than 1 year of non antiviral therapy, and antiviral therapy had begun within 8 weeks before and after liver biopsy (antiviral starting point); pathological diagnosis had been made again after 2 to 3 years of antiviral therapy (antiviral ending point); complete outpatient and inpatient records, and complete routine laboratory and ultrasonic data at antiviral starting point and ending point (within 4 weeks before and after liver biopsy) had been left; The matching serum had been taken at antiviral starting point and ending point (within 4 weeks before and after liver biopsy). 2. Inclusion criteria for patients in Group II: HBsAg positive chronic hepatitis; pathological diagnosis of liver cirrhosis was made after more than 1 year of non antiviral therapy, and antiviral therapy began within 8 weeks before and after liver biopsy (antiviral starting point); pathological diagnosis will be made again after 2 to 3 years of antiviral therapy (antiviral ending point); complete outpatient and inpatient records, and complete routine laboratory and ultrasonic data at antiviral starting point (within 4 weeks before and after liver biopsy) was left; The matching serum was taken at antiviral starting point (within 4 weeks before and after liver biopsy).

Exclusion criteria

Exclusion criteria: 1. Combined with other hepatitis, schistosomiasis liver disease, drug-induced liver injury, alcoholic liver disease, hereditary liver disease, endocrine and metabolic diseases, autoimmune diseases, blood system diseases, chronic intestinal diseases, uncontrolled heart/lung diseases and kidney diseases; 2. severe infection of any site except spontaneous bacterial peritonitis (Fever more than 3 days, inflammatory and anti-inflammatory symptoms more than 3 weeks) occurred within 4 weeks before and after liver biopsy; 3. serum HBV DNA > 1000 IU/mL after six months of antiviral therapy; 4. poor adherence or combined with anti-fibrotic, hepato-protective, and inflammatory drugs; not suitable for liver biopsy the investigators concluded.

Design outcomes

Primary

MeasureTime frame
SEN, SPE, ACC, AUC of ROC, PPV, NPV;

Countries

China

Contacts

Public ContactZhan-qing Zhang

Shanghai Public Health Clinical Center

doctorzzqsphc@163.com+86 18916039958

Outcome results

None listed

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