Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B
NCT ID: NCT02482272
Last Updated: 2015-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2015-05-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lamivudine plus Adefovir or Adefovir
Lamivudine+Adefovir or Adefovir for 48 weeks
Lamivudine
Lamivudine 100mg/day orally
Adefovir
Adefovir 10mg/day orally
Entecavir plus Adefovir
Entecavir+Adefovir for 48 weeks
Adefovir
Adefovir 10mg/day orally
Entecavir
Entecavir 1mg/day orally
Interventions
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Lamivudine
Lamivudine 100mg/day orally
Adefovir
Adefovir 10mg/day orally
Entecavir
Entecavir 1mg/day orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Young-Hwa Chung
PhD
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Young Hwa Chung
Role: primary
Other Identifiers
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ENTADE
Identifier Type: -
Identifier Source: org_study_id