Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B

• Status: Unknown status
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or Adefovir

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

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Adefovir; Adefovir dipivoxil; Entecavir; Lamivudine

Criteria

Inclusion Criteria:

• Chronic hepatitis B

• Age ≥ 20 year old

• Currently taking Lamivudine and Adefovir combination therapy or Adefovir monotherapy for chronic HBV infection for 24 weeks

• Proven Lamivudine resistant mutation

• HBV DNA levels at screening ≥ 15 IU/mL

• Females must be post-menopausal, unable to conceive, or test negative for pregnancy via urine test

• Patient is able to give written informed consent prior to study start and to comply with the study requirements

Exclusion Criteria:

• A history or current of decompensated cirrhosis or hepatocellular carcinoma

• Currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy

• Co-infected with HCV or HIV

• A history of organ transplantation

• Pregnant or breast-feeding

• Current clinically relevant of abuse of alcohol or drugs.

• Significant immunocompromised, gastrointestinal, renal(serum creatinine ≥ 1.5 mg/dL), hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy

• malignancy in previous 5 years