NCT03568578

A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of our study is to validate the non-invasive model which was constructed by our previous study for evaluating liver fibrosis or cirrhosis caused by hepatitis B virus in mainland China and to find a therapeutic regimen to reverse liver fibrosis and cirrhosis.

Detailed description

450 patients who are infected with hepatitis B virus for at least 6 months will be included in the study. They will be divided into two groups. One group will be treated with Entecavir while another treated with Entecavir and Anluohuaxian Pill. Liver biopsy samples and blood samples from the patients will be used to validate the non-invasive model. Furthermore, the samples will be used to evaluate if Anluohuaxian Pill could reverse liver fibrosis and cirrhosis.

Conditions

• Hepatitis B
• Liver Fibrosis

Interventions

Type	Name	Description
DRUG	Entecavir 0.5 mg	Patients in this group will be given Entecavir 0.5 mg a day for 2 years.
DRUG	Anluohuaxian Pill 12g	Patients in this group will be given Entecavir 0.5 mg and Anluohuaxian Pill 12g a day for 2 years

Timeline

• Start date: 2018-01-28
• Primary completion: 2020-12-31
• Completion: 2021-09-30
• First posted: 2018-06-26
• Last updated: 2018-06-27

Locations

18 sites across 1 country: China