A Study to Evaluate Tenofovir Disoproxil Fumarate (DF) in Asian-American Adults With Chronic Hepatitis B Infection
NCT ID: NCT00736190
Last Updated: 2011-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2008-08-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TDF
300-mg tablet (marketed formulation) taken orally once daily
Tenofovir disoproxil fumarate
300-mg tablet (marketed formulation) taken orally once daily
Interventions
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Tenofovir disoproxil fumarate
300-mg tablet (marketed formulation) taken orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Asian-American, defined as a person of self-reported Asian ancestry who is residing in the United States (US)
* 18 through 75 years of age, inclusive
* Documented chronic HBV infection, defined as positive serum HBsAg =/\> 6 months
* HBV DNA =/\> 10,000 copies/mL (PCR method)
* ALT \> ULN and \</= 10 × ULN at screening or within the past 12 months prior to screening
* Willing and able to provide written informed consent
* Negative serum beta-human chorionic gonadotropin (HCG) pregnancy test (females of child-bearing potential)
* Estimated glomerular filtration rate (creatinine clearance) =/\> 60 mL/min/1.73m\^2 by the Cockcroft-Gault equation
* Adequate hematologic function (absolute neutrophil count =/\> 1,500/mm\^3; hemoglobin =/\> 10.0 g/dL)
* No prior TDF therapy; participants may have taken \< 12 weeks of oral anti-HBV therapy, with the last dose =/\> 16 weeks prior to screening; participants may have received prior interferon, but must have discontinued interferon therapy =/\> 6 months prior to screening
Exclusion Criteria
* Males and females of reproductive potential who are not willing to use an effective method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.
* Decompensated liver disease defined as direct (conjugated) bilirubin \> 1.2 X ULN, prothrombin time (PT) \> 1.2 X ULN, platelets \< 150,000/mm3, or serum albumin \< 3.5 g/dL
* Prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy) or variceal hemorrhage
* Receipt of prior TDF treatment
* Receipt of =/\> 12 weeks of oral anti-HBV nucleoside/nucleotide therapy, or receipt of ANY oral anti-HBV treatment \< 16 weeks prior to screening
* Receipt of interferon (pegylated or not) therapy within 6 months of the Screening Visit
* alpha-fetoprotein \> 50 ng/mL
* Evidence of hepatocellular carcinoma (HCC)
* Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV)
* History of significant renal disease (eg, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis, acute tubular necrosis, other renal disease)
* History of significant bone disease (eg, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, multiple bone fractures)
* Significant cardiovascular, pulmonary or neurological disease
* Evidence of a gastrointestinal malabsorption syndrome that may interfere with absorption of orally administered medications
* History of solid organ or bone marrow transplantation
* Ongoing therapy with any of the following: nephrotoxic agents, competitors of renal excretion (eg, probenecid), systemic chemotherapeutic agents, systemic corticosteroids, Interleukin-2 (IL-2) and other immunomodulating agents, investigational agents (except with the expressed approval of the Sponsor); administration of any of the above medications must be discontinued at least 30 days prior to the Baseline Visit and for the duration of the study period
* Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
* Any other condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Locations
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Fountain Valley, California, United States
Hacienda Heights, California, United States
Los Angeles, California, United States
Monterey Park, California, United States
Mountain View, California, United States
Oakland, California, United States
Palo Alto, California, United States
San Jose, California, United States
Hamden, Connecticut, United States
Baltimore, Maryland, United States
Laurel, Maryland, United States
Silver Spring, Maryland, United States
Englewood, New Jersey, United States
Brooklyn, New York, United States
Flushing, New York, United States
New York, New York, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Fairfax, Virginia, United States
Falls Church, Virginia, United States
Bellevue, Washington, United States
Countries
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References
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Pan CQ, Chan S, Trinh H, Yao A, Bae H, Lou L. Similar efficacy and safety of tenofovir in Asians and non-Asians with chronic hepatitis B. World J Gastroenterol. 2015 May 14;21(18):5524-31. doi: 10.3748/wjg.v21.i18.5524.
Pan CQ, Trinh H, Yao A, Bae H, Lou L, Chan S; Study 123 Group. Efficacy and safety of tenofovir disoproxil fumarate in Asian-Americans with chronic hepatitis B in community settings. PLoS One. 2014 Mar 4;9(3):e89789. doi: 10.1371/journal.pone.0089789. eCollection 2014.
Other Identifiers
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GS-US-174-0123
Identifier Type: -
Identifier Source: org_study_id