NCT02327663

Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Asian-Pacific Alliance of Liver Disease, Beijing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.

Detailed description

Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent. The investigators design this trial to test the effect of FTC in Chinese CHB which including naive HBeAg positive and Negative CHB patients. Response guided therapy strategy is adopted for patients who can not achieve HBV DNA negativity at week 24 FTC treatment, which means FTC and adefovir are combined for these patients.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Emtricitabine	emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2014-12-30
• Last updated: 2014-12-30