yuganlong capsule combined with entecavir tablets in the treatment of liver fibrosis in chronic hepatitis B clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-16010010

Enrollment

Unknown

Registered

2016-11-24

Start date

2016-07-01

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

All People:N/A

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 60 years male and female; 2. to meet the diagnostic criteria for chronic hepatitis B, including the compensation phase of liver cirrhosis (<7 score Child-Pugh points); 3. ALT<5 times ULN (standard cap); 4. Within 24 weeks, liver biopsy confirmed obvious hepatic fibrosis, Ishak = F3, and not used antiviral drugs (interferon, lamivudine, adefovir, entecavir, telbivudine, for Nuo Fuwei) Drug resistance; 5. HBV resistant to drug resistant; 6. in accordance with the use of nucleoside analogues antiviral indications of chronic hepatitis patients.

Exclusion criteria

Exclusion criteria: 1. patients with alcoholic and drug resistance, genetic, immune and other viral or non viral chronic hepatitis; 2. entecavir resistant patients; 3. of diagnosed chronic hepatitis B or severe hepatitis tendency; 4. the liver function of patients with decompensated liver cirrhosis and liver cancer; 5. the selected 3 months before had upper gastrointestinal bleeding; 6. TBiL>3 times ULN; 7. AFP>100 g/L; 8. Taking the drugs of anti liver fibrosis was observed within 6 months before (Fuzheng Huayu capsule / tablet, Fufangbiejiaruanganpian, Anluohuaxianwan); 9. with cardiovascular, lung and kidney, endocrine, nervous system and blood disease; 10. of active peptic ulcer; 11. in 30 days before the test in the complications of surgery; 12. for pregnant women, pregnant or lactating women; 13. the test drug allergic to any component or not tolerated; 14. have mental disorders, alcoholism, drug or other substance abusers; 15. the selected 3 months before in any drug test.

Design outcomes

Primary

Measure	Time frame
4 indexes of hepatic fibrosis ;liver function;HBV test;HBV DNA;	—

Secondary

Measure	Time frame
Fibroscan;Liver tissue inflammation score;	—

Countries

China

Contacts

Public ContactChunguang Yang

Wu Han Junan Pharmaceutical Co.Ltd

328791162@qq.com+86 18627818152

Outcome results

None listed

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