Efficacy Optimizing Research of Lamivudine Therapy (EXPLORE)

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 4

Conditions: Compensated Chronic Hepatitis B

Treatments: Drug: lamivudine; Drug: lamivudine, adefovir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01088009

MOH-02

Details and patient eligibility

About

The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.

Enrollment: 366 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 and HBeAg positive at study screening; Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months;

Exclusion criteria

• History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
• other protocol defined inclusion/exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

366 participants in 3 patient groups

early add-on

Experimental group

Treatment:

Drug: lamivudine

Drug: lamivudine

SOC

Active Comparator group

Description:

Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily

Treatment:

Drug: lamivudine

Drug: lamivudine

De-novo combination

Other group

Description:

patients in this arm will receive oral lamivudine 100mg and adefovir 10mg for 104 weeks

Treatment:

Drug: lamivudine, adefovir