Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asian-Pacific Alliance of Liver Disease, Beijing
• Collaborators: Beijing Ditan Hospital; Hebei Medical University Pharmaceutical Factory; National Health and Family Planning Commission, P.R.China
• Treatments: Adefovir; Adefovir dipivoxil; Emtricitabine

Criteria

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