Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus
NCT ID: NCT00410202
Last Updated: 2013-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
629 participants
INTERVENTIONAL
2008-03-31
2012-07-31
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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Entecavir
With the option of adding tenofovir at week 48. (This does not apply to Korea)
Entecavir
Tablets, Oral, 1mg, once daily, 100 weeks
Tenofovir
Tablets, Oral, 300 mg, once daily
Adefovir + Lamivudine
Adefovir
Tablets, Oral, 10mg, once daily, 100 weeks
Lamivudine
Tablets, Oral, 100mg, once daily, 100 weeks
Entecavir + Adefovir
Entecavir
Tablets, Oral, 1mg, once daily, 100 weeks
Adefovir
Tablets, Oral, 10mg, once daily, 100 weeks
Interventions
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Entecavir
Tablets, Oral, 1mg, once daily, 100 weeks
Tenofovir
Tablets, Oral, 300 mg, once daily
Adefovir
Tablets, Oral, 10mg, once daily, 100 weeks
Lamivudine
Tablets, Oral, 100mg, once daily, 100 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have a history of previous LVD treatment at screening, and must have evidence of at least 1 LVD resistance substitution (valine, isoleucine, or serine) at reverse transcriptase codon 204 (M204V/I/S)
* Nucleoside- and nucleotide-naive, except for LVD, and had chronic hepatitis B (HBV) infection
* Compensated liver function and must have met ALL of the following criteria:International normalization ratio (INR) ≤ 1.5; Serum albumin ≥ 3 g/dL (≥ 30 g/L); Serum total bilirubin ≤ 2.5 mg/dL (≤ 42.75 μmol/L)
* HBV DNA \> 1.72 x 10\*4\* IU/mL (approximately 10\*5\* copies/mL)
* Documentation of hepatitis B e antigen (HBeAg) positive and hepatitis B e antibody (HBeAb) negative status at screening
* alanine aminotransferase (ALT) ≤ 10 \* upper limit of normal (ULN) at screening
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study (and for up to 6 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
* WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. Post menopausal is defined as:
* Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential
* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 72 hours prior to the start of investigational product
Exclusion Criteria
* Coinfection with human immunodeficiency virus, hepatitis C virus , or hepatitis D virus
* Women who are pregnant or breastfeeding
* Sexually active fertile men not using effective birth control if their partners were WOCBP
* Laboratory values out of protocol-specified range
16 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Connecticut Health Center
Farmington, Connecticut, United States
Local Institution
Concord, New South Wales, Australia
Local Institution
Randwick, New South Wales, Australia
Local Institution
Porto Alegre Rs, Rio Grande do Sul, Brazil
Local Institution
Calgary, Alberta, Canada
Local Institution
Athens, , Greece
Local Institution
Hong Kong, Hong Kong, Hong Kong
Local Institution
Shatin, New Territories, Hong Kong
Local Institution
Tai Po, , Hong Kong
Local Institution
Lucknow, Uttar Pradesh, India
Local Institution
Ahmedabad, , India
Local Institution
Chandigarh, , India
Local Institution
Indore, , India
Local Institution
Ludhiana, , India
Local Institution
New Delhi, , India
Local Institution
Vellore, , India
Local Institution
Jakarta, , Indonesia
Local Institution
Antella, Firenze, , Italy
Local Institution
Kota Kinabalu, Sabah, Malaysia
Local Institution
Kuala Lumpur, , Malaysia
Local Institution
Cebu City, , Philippines
Local Institution
Manila, , Philippines
Local Institution
Chorzów, , Poland
Local Institution
Kielce, , Poland
Local Institution
Lodz, , Poland
Local Institution
Lublin, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Moscow, , Russia
Local Institution
Moscow, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Singapore, , Singapore
Local Institution
Seoul, Dongdaemun-Gu, South Korea
Local Institution
Ulsan, Donggu, South Korea
Local Institution
Ansan-si, Gyeonggi-do, South Korea
Local Institution
Anyang-si, Gyeonggi-do, South Korea
Local Institution
Bucheon-si, Gyeonggi-do, South Korea
Local Institution
Seongnam-si, Gyeonggi-do, South Korea
Local Institution
Suwon, Gyeonggi-do, South Korea
Local Institution
Koyang, Ilsanseo Gu, South Korea
Local Institution
Incheon, Jung-Gu, South Korea
Local Institution
Seoul, Nowon-Gu, South Korea
Local Institution
Chuncheon, , South Korea
Local Institution
Daegu, , South Korea
Local Institution
Gangneung, , South Korea
Local Institution
Incheon, , South Korea
Local Institution
Pusan, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Suwon, , South Korea
Local Institution
Yangsan, , South Korea
Local Institution
Kaohsiung City, , Taiwan
Local Institution
Tainan R.o.c., , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taoyuan District, , Taiwan
Local Institution
Bangkok, , Thailand
Local Institution
Chiang Mai, , Thailand
Local Institution
Bornova Izmir, , Turkey (Türkiye)
Local Institution
Trabzon, , Turkey (Türkiye)
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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AI463-111
Identifier Type: -
Identifier Source: org_study_id