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
104 participants
INTERVENTIONAL
2012-08-31
2014-05-31
Brief Summary
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Earlier switching to combination with the most potent regimen will be more effective to achieve virologic response(VR) and prevent further resistance emergence.
All subjects will orally take assigned drugs once daily for 48 weeks. All subjects will be assessed at baseline and every three months thereafter. Evaluations at each visit will include vital signs, physical examinations, laboratory tests, HBV DNA levels and adverse events. At baseline and every six months thereafter, serum will be assayed for HBV serology. Genotypic analysis will be performed at baseline and 48 weeks.
Detailed Description
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2. However, several local literatures reported a substantial proportion of patients treated with LAM plus ADV combination therapy showed a persistently inadequate or partial virologic response('VR') and YMDDm still maintained in spite of under rescue combination therapy.
3. Due to the unavailability of TDF in Korea, ETV plus ADV combination has being considered a better salvage therapy with non-overlapping cross-resistance profiles in pts who fail to LAM plus ADV rescue therapy and local report demonstrated that the rate of VR was significantly higher with ETV+ADV switching group than LAM+ADV continuation group in partial responder to LAM plus ADV combination rescue therapy for LAM resistance.
4. Hence, more earlier combination therapy with the most potent Nucleoside and Nucleotide analogue would be a promising salvage treatment for previous NA treatment failures but comparative prospective trials are limited.
5. Therefore, this study will investigate the greater effectiveness and safety of switching to the most potent combination versus maintaining LAM(or LdT) plus ADV and also compare the rate of VR based on the HBV DNA cut-off level at switching - more than and less than 20,000 IU/mL.
All subjects will orally take assigned drugs once daily for 48 weeks. All subjects will be assessed at baseline and every three months thereafter. Evaluations at each visit will include vital signs, physical examinations, laboratory tests, HBV DNA levels and adverse events. At baseline and every six months thereafter, serum will be assayed for HBV serology. Genotypic analysis will be performed at baseline and 48 weeks.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A:
Maintaining LAM/LdT+ADV combination Lamivudine 100mg / Telbivudine 600mg +Adefovir 10mg
Group A (Zeffix, Sebivo, Hepsera)
Maintaining LAM/LdT+ADV combination Lamivudine 100mg / Telbivudine 600mg +Adefovir 10mg
Group B
Switching to ETV plus TDF combination Entecavir 1.0mg + Tenofovir 300mg
Group B (Baraclude, Viread)
Switching to ETV plus TDF combination Entecavir 1.0mg + Tenofovir 300mg
Interventions
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Group A (Zeffix, Sebivo, Hepsera)
Maintaining LAM/LdT+ADV combination Lamivudine 100mg / Telbivudine 600mg +Adefovir 10mg
Group B (Baraclude, Viread)
Switching to ETV plus TDF combination Entecavir 1.0mg + Tenofovir 300mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. History of HBsAg positive for more than 6 months
3. History of genotypic resistance to LAM or LdT (YMDDm)
4. Partial responder (HBV DNA ≥ 60 IU/mL) currently receiving antiviral combination rescue therapy for at least 24 weeks of treatment with LAM+ADV or LdT+ADV
5. Hepatitis B e Antigen(HBeAg)-positive and -negative
6. Compensated liver disease (Child-Pugh A)
7. Signed written informed consent after being instructed about the objective and procedure of the clinical study
Exclusion Criteria
2. Most previous treatment of other than LAM+ADV and LdT+ADV
3. Subjects with Alanine Aminotransferase(ALT) \> 10xUpper Limit of normal(ULN)
4. Co-infected with hepatitis C virus(HCV) or HIV
5. Pregnant or lactating woman
6. Subject who needs long-term administration of drugs including immunosuppressive agents, agents related to high risk in the hepatic/renal toxicity, agents influencing renal excretion
7. History of liver transplantation or planned for liver transplantation
8. Subject who was diagnosed malignant tumor and has been receiving chemotherapy
9. Subject who has HCC history or who shows potential hepatocellular carcinoma (HCC) finding such as suspicious region in the radiologic exam(abdominal US or CT) or serum Alpha Feto Protein(AFP) elevation
10. Renal Insufficiency (CLcr \< 50ml/min based on Cockcroft-Gault equation considering weight, ages and serum creatinine)
11. Subject who has a liver disease other than chronic hepatitis B (e.g. hemochromatosis, Wilson's disease, alcoholic liver disease, nonalcoholic fatty liver disease, alpha 1-antitrypsin deficiency etc.)
12. Subject who has a history of hypersensitivity to study drug or its ingredients
13. Subject who is involved in other clinical trial within 60 days prior to study entry
14. Subject who the investigator deems inappropriate to participate in this study
20 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Seoul St. Mary's Hospital
OTHER
The Catholic University of Korea
OTHER
Soonchunhyang University Hospital
OTHER
Pusan National University Hospital
OTHER
Kyungpook National University Hospital
OTHER
Hallym University Medical Center
OTHER
Chonbuk National University Hospital
OTHER
Yonsei University
OTHER
Responsible Party
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Sang Hoon Ahn
Associate Professor
Principal Investigators
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Sang Hoon Ahn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yonsei University
References
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Woo HY, Park JY, Bae SH, Kim CW, Jang JY, Tak WY, Kim DJ, Kim IH, Heo J, Ahn SH. Entecavir+tenofovir vs. lamivudine/telbivudine+adefovir in chronic hepatitis B patients with prior suboptimal response. Clin Mol Hepatol. 2020 Jul;26(3):352-363. doi: 10.3350/cmh.2019.0044n. Epub 2020 May 28.
Other Identifiers
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AI463-274
Identifier Type: -
Identifier Source: org_study_id