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

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B

Treatments: Drug: Entecavir; Drug: Entecavir, Adefovir

Study type: Interventional

Funder types: Other

Identifiers

NCT01341743

MOH-04

Details and patient eligibility

About

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

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

A

Active Comparator group

Description:

oral entecavir 1mg daily for 104 weeks

Treatment:

Drug: Entecavir

B

Active Comparator group

Description:

oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks

Treatment:

Drug: Entecavir, Adefovir

Drug: Entecavir, Adefovir

C

Active Comparator group

Description:

oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks

Treatment:

Drug: Entecavir, Adefovir

Drug: Entecavir, Adefovir