Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients

Phase 4

• Conditions: Hepatitis B, Chronic; Fibrosis
• Interventions: Drug: Emtricitabine plus adefovir dipivoxil

• Registration Number: NCT02327689
• Lead Sponsor: Asian-Pacific Alliance of Liver Disease, Beijing

Brief Summary

This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients.

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 plus adefovir dipivoxil in cirrhosis patients. The investigators design this trial to test the effect of FTC plus adefovir dipivoxil in Chinese naive compensated and decompensated HBV related cirrhosis patients.

Study Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2014-12-29
• Last Update Submitted: 2014-12-29
• Study First Posted: 2014-12-30
• Last Update Posted: 2014-12-30
• Study Start: 2015-01
• Primary Completion: 2015-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Dignosed cirrhosis patients
• HBsAg positive for more than 6 months
• HBV DNA detectable
• Nucleoside/nucleotide naive patients

Exclusion Criteria

• Diagnosed HCC with AFP and ultrasound, CT or MRI
• Creatine >130μmol/L or Ccr < 70mL/min
• Hemoglobin <100g/L
• Coinfected with HAV,HEV,HCV,HDV or HIV
• ANA > 1:100
• Uncontrolled cardiovascular diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer;
• Drug abuse or alcohol addiction
• Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine
• Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial
• Underwent liver transplantation or liver transplantation in schedule
• Allergic to nucleoside or nucleotide analogues
• Pregnancy or in breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
compensated HBV related cirrhosis patients	Emtricitabine plus adefovir dipivoxil	Chinese naive compensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks
decompensated HBV related cirrhosis patients	Emtricitabine plus adefovir dipivoxil	Chinese naive decompensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks

Primary Outcome Measures

Name	Time	Method
virological response rate	week 96	HBV DNA \< 500 copies/ml

Secondary Outcome Measures

Name	Time	Method
HBV DNA negativity rate	week 24, 48 and 72	HBV DNA \< 500 copies/ml
HBV DNA decrease level	week24, 48, 72 and 96	HBV DNA decrease compared with baseline（log10 copies/ml）
biochemical response	week 24,48,72 and 96	ALT normalization
HBeAg loss	week 24,48,72 and 96	HBeAg loss in HBeAg positive group
HBeAg seroconversion	week 24,48,72 and 96	HBeAg seroconversion in HBeAg positive group
HBeAg reversion	week 24,48,72 and 96	HBeAg positive in Baseline HBeAg negativie group patients
change of MELD score and Child-Pugh score	week 24,48,72 and 96	change of MELD score and Child-Pugh score in both groups
HBsAg loss	week 24,48,72 and 96	HBsAg loss in both group
HBsAg seroconversion	week 24,48,72 and 96	HBsAg loss and anti-HBs positive
HBV genetic resistance to emtricitabine and adefovir	week 24,48,72 and 96	HBV genetic resistance to emtricitabine and adefovir
adverse event	week 24,48,72 and 96	type and rate of adverse events;type and rate of severe adverse event
incidence of HCC	week 24,48,72 and 96	incidence of HCC in both groups