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Effect of combination therapy with Fu Fang Bie Jia Ruan Gan Pian and adefovir dipivoxil on liver fibrosis in chronic hepatitis B patients: a randomised controlled clinical study.

Effect of combination therapy with Fu Fang Bie Jia Ruan Gan Pian and adefovir dipivoxil on liver fibrosis in chronic hepatitis B patients: a randomised controlled clinical study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002104
Enrollment
Unknown
Registered
2012-04-12
Start date
2011-06-01
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

1:Fu Fang Bie Jia Ruan Gan Pian plus adefovir dipivoxil
2:adefovir dipivoxil

Sponsors

302 Military Hospital of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Chronic HBV infected patients (including chronic hepatitis B and liver cirrhosis) based on diagnostic criteria of 2010 China clinical practice guidelines of chronic hepatitis B (updated); (2) Males or females with age from 18 to 65 years old, capable of signing the informed consent; (3) Chronic hepatitis B patients with ALT >=80 U/L or METAVIR >=F2 (HBeAg positive, HBV DNA >=20000 IU/ml; HBeAg negative, HBV DNA >=2000 IU/ml); (4) Compensated cirrhosis patients with serum positive HBV DNA.

Exclusion criteria

Exclusion criteria: (1) Patients combined with liver failure, decompensated cirrhosis, liver tumor, cardio-cerebrovascular disease, The blood system disease, or psychiatric disorders; (2) Patients enrolled in other clinical trials; (3) Patients with poor compliance or other factors which may lead to mistakes in determine of effect or safety; (4) Allergy, pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
HBV DNA;FibroScan;liver biopsy;

Secondary

MeasureTime frame
ALT normalized rate;HBeAg seroconversion;hepatic decompensation rate;drug resistance rate;B ultrasoun;

Contacts

Public ContactChen Guofeng
bjchen302@yahoo.com.cn+86 010 66933427

Outcome results

None listed

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