Overview

Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nanfang Hospital of Southern Medical University
Collaborator:
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
Treatments:
Adefovir
Adefovir dipivoxil
Entecavir
Criteria
Inclusion Criteria:

- Male or female aged 18-65 years;

- Capable of understanding and signing the informed consent. Willing to comply with the
study requirements;

- Serum HBsAg positive and ALT<10ULN at study screening;

- Patients have been treated with one nucleoside/nucleotide analogue for more than 6
months and are still on treatment;

Exclusion Criteria:

- History of viral breakthrough or genotypic resistance on previous therapy;

- History of decompensated liver function, or current signs/symptoms of decompensation
e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;

- Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of
possible HCC;

- Other protocol defined exclusion criteria.