Clinical trial NCT02482272: Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B
Official title: Efficacy and Safety of Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With Chronic Hepatitis B Who Have Resistant Mutants to Lamivudine and Show Suboptimal Response to Combination of Lamivudine Plus Adefovir or Adefovir Monotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Proportion of patients with HBV DNA<15IU/mL
timeFrame: week 48
Secondary outcomes:
measure: Proportion of patients with HBV DNA<15IU/mL
timeFrame: Day1, week12, week 24, week 36, week 48
measure: The change of HBV DNA from the baseline
timeFrame: week 48
measure: Proportion of patients with ALT normalization
timeFrame: Day1, week12, week 24, week 36, week 48
measure: Proportion of patients with HBeAg loss and/or seroconversion
timeFrame: Day1, week12, week 24, week 36, week 48
measure: The change of HBsAg from the baseline
timeFrame: week 48
measure: Proportion of patients with HBsAg loss and/or seroconversion
timeFrame: week 24, week 48
measure: Proportion of patients who experienced virologic breakthrough
timeFrame: week 48
measure: Assessment the safety in all patients (composite measure of AE, labs, phys. exam, vital signs)
timeFrame: week 48
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: