Clinical study on the antifibrotic activity of Fuzhenghuayu tablet combined with Entekavir in chronic hepatitis B subjects with hepatic fibrosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001377

Enrollment

Unknown

Registered

2011-06-09

Start date

2011-03-17

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

liver fibrosis

Interventions

2:ETV+placebo

1:ETV+FZHY

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 70 years, inclusive;History with chronic hepatitis B>=6 mo; ALT 2.0*10^4IU/ml; patients with HBeAg negtive, HBV DNA > 2.0*10^3 IU/ml; Prior treatment with antiviral must have been discontinued at least 6 mo; Availability and willingness of subject to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. gastrointestinal bleeding in 3 months; 2. TBiL>2-folds of normal level; 3. AFP>50 ug/L ; 4. BMI index >30; 5. Decompensated post-hepatisis cirrhosis or hepatisis carcinoma; 6. Alcoholic, drug induced, infectious, inherited, immune and other viral liver diseases; 7. Complicated by serious cardiovascular, renal, endocrine, hematologic; nervous and mental diseases; 8. women with pregnancy or during lactation.

Design outcomes

Primary

Measure	Time frame
Liver function;	—

Secondary

Measure	Time frame
HBV DNA;Fibroscan Kpa;Liver fibrosis stage;Liver inflammation grade;	—

Countries

China

Contacts

Public ContactQing Xie

xieqingrj@yahoo.com.cn+86 021-64370045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026