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The evaluation of FibroScan and APRI diagnosing inflammation and fibrosis in patients with chronic hepatitis B: a clinical study of large sample completed by single-center

The evaluation of FibroScan and APRI diagnosing inflammation and fibrosis in patients with chronic hepatitis B: a clinical study of large sample completed by single-center

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DRD-16009773
Enrollment
Unknown
Registered
2016-11-08
Start date
2012-05-05
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Chronic Hepatitis B

Interventions

Gold Standard:
Index test:

Sponsors

Foshan Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 67 Years

Inclusion criteria

Inclusion criteria: According to the EASL clinical practice guidelines: Management of chronic hepatitis B virus infection and the Chinese guideline of prevention and treatment for chronic hepatitis B: a 2015 update ,the inclusion criteria were determined: 1. more than six months of a history of hepatitis B or HBsAg positive; 2. HBV DNA positive (=2000 IU/mL); 3. continuous or repeated abnormal of ALT or inflammation of liver tissue; 4. aged 15 to 67 years.

Exclusion criteria

Exclusion criteria: 1. liver cirrhosis or liver cancer confirmed by clinical diagnosis; 2. high level of TBIL (=150umol/L)or liver failure; 3. Complicated with metabolic diseases or autoimmune liver diseases; 4. co-infected with HIV, HCV and HDV; 5. abused alcohol or illegal drugs, or participated in other drug trials within 30 days; 6. With a history of using nucleoside analogues, interferon, immune modulators and other anti-hepatic fibrosis drugs within 24 weeks; 7. receiving the treatment of anti-inflammatory and protect liver or taking related drugs such as glycyrrhizin and so on; 8. mental diseases or other serious viscera diseases; 9. pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
ALT;AST;TBIL;HBeAg;HBV DNA;APRI;FibroScan (Kpa);hepatic pathology (G, S);The degree of fatty liver;FibroScan (IQR/M);the number of liver portal area;PLT;

Secondary

MeasureTime frame
age;gender;

Countries

China

Contacts

Public ContactKaiping Jiang

Foshan Hospital of Traditional Chinese Medicine

jkpingfs@126.com+86 13809213185

Outcome results

None listed

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