Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil
NCT ID: NCT00307489
Last Updated: 2011-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2006-03-31
2010-10-31
Brief Summary
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Subjects with confirmed (within 4 weeks) plasma HBV DNA ≥ 400 copies/mL during double blind treatment at Week 24 or any time thereafter have the option of receiving 12 weeks of open-label FTC/TDF which may be continued through the end of the 168-week treatment period if there is a virologic response (HBV DNA \< 400 copies/mL). Alternatively, subjects with confirmed HBV DNA \< 400 copies/mL at or any time after Week 24 of double-blind treatment may continue blinded therapy up to Week 168 at the discretion of the investigator. If, in the investigator's opinion, it is felt that continued blinded treatment beyond 24 weeks in subjects with confirmed HBV DNA ≥ 400 copies/mL is not beneficial, the subject may discontinue the study and begin commercially available HBV therapy rather than initiate open-label FTC/TDF.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
TDF
tenofovir DF
300 mg tablet, once daily (QD)
2
FTC/TDF
emtricitabine /tenofovir DF
emtricitabine 200 mg/tenofovir DF 300 mg once daily (combination tablet)
Interventions
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emtricitabine /tenofovir DF
emtricitabine 200 mg/tenofovir DF 300 mg once daily (combination tablet)
tenofovir DF
300 mg tablet, once daily (QD)
Eligibility Criteria
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Inclusion Criteria
* Chronic HBV infection, defined as positive serum HBsAg for at least 6 months
* Active chronic HBV infection with all the following:
1. Currently treated with adefovir dipivoxil 10 mg QD (for at least 24 weeks but not more than 96 weeks)
2. HBeAg positive or negative at screening
3. Plasma HBV DNA \>/= 1000 copies/mL at screening (irrespective of HBeAg status)
4. Serum ALT less than 10 times the upper limit of normal (ULN)
5. Calculated creatinine clearance of at least 70 mL/min using the Cockcroft-Gault formula
6. Hemoglobin at least 8 g/dL
7. Neutrophils at least 1,000 /mm3
* Nucleoside naive except for lamivudine (\>/= 12 weeks of therapy)
* Negative serum beta human chorionic gonadotropin
* Compliant with adefovir dipivoxil
* Willing and able to provide written informed consent
Exclusion Criteria
* Male or females of reproductive potential who are unwilling to use an effective method of contraceptive while enrolled in the study. For males, condoms should be used and for females, a barrier contraception method should be used
* Decompensated liver disease defined as conjugated bilirubin greater than 1.5 times ULN, prothrombin time (PT) greater than 1.5 times ULN, platelets less than 75,000/mm3, serum albumin less than 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
* Prior use of tenofovir DF or entecavir
* Received treatment with interferon or pegylated interferon within 6 months of the screening visit
* Evidence of hepatocellular carcinoma (HCC); for example, alpha-fetoprotein greater than 50 ng/mL or by any other standard of care measure.
* Co-infection with HCV (based on serology), human immunodeficiency virus (HIV), or hepatitis delta virus (HDV)
* Significant renal, cardiovascular, pulmonary, or neurological disease.
* Received solid organ or bone marrow transplantation.
* Is currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion
* Has proximal tubulopathy
* Known hypersensitivity to the study drugs (tenofovir DF or emtricitabine/tenofovir DF), the metabolites (tenofovir or emtricitabine) or formulation excipients
18 Years
69 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen J Rossi, PharmD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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San Francisco, California, United States
San Jose, California, United States
Flushing, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Angers, , France
Clichy, , France
Lille, , France
Lyon, , France
Marseille, , France
Rouen, , France
Strasbourg, , France
Berlin, , Germany
Berlin, , Germany
Bonn, , Germany
Erlangen, , Germany
Essen, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Hanover, , Germany
Herne, , Germany
München, , Germany
Seville, , Spain
Countries
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References
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van Bommel F, Zollner B, Sarrazin C, Spengler U, Huppe D, Moller B, Feucht HH, Wiedenmann B, Berg T. Tenofovir for patients with lamivudine-resistant hepatitis B virus (HBV) infection and high HBV DNA level during adefovir therapy. Hepatology. 2006 Aug;44(2):318-25. doi: 10.1002/hep.21253.
Marcellin P, Heathcote EJ, Buti M, Gane E, de Man RA, Krastev Z, Germanidis G, Lee SS, Flisiak R, Kaita K, Manns M, Kotzev I, Tchernev K, Buggisch P, Weilert F, Kurdas OO, Shiffman ML, Trinh H, Washington MK, Sorbel J, Anderson J, Snow-Lampart A, Mondou E, Quinn J, Rousseau F. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med. 2008 Dec 4;359(23):2442-55. doi: 10.1056/NEJMoa0802878.
Reijnders JG, Janssen HL. Potency of tenofovir in chronic hepatitis B: mono or combination therapy? J Hepatol. 2008 Mar;48(3):383-6. doi: 10.1016/j.jhep.2007.12.006. Epub 2007 Dec 31. No abstract available.
Tan J, Degertekin B, Wong SN, Husain M, Oberhelman K, Lok AS. Tenofovir monotherapy is effective in hepatitis B patients with antiviral treatment failure to adefovir in the absence of adefovir-resistant mutations. J Hepatol. 2008 Mar;48(3):391-8. doi: 10.1016/j.jhep.2007.09.020. Epub 2008 Jan 3.
van Bommel F, de Man RA, Wedemeyer H, Deterding K, Petersen J, Buggisch P, Erhardt A, Huppe D, Stein K, Trojan J, Sarrazin C, Bocher WO, Spengler U, Wasmuth HE, Reinders JG, Moller B, Rhode P, Feucht HH, Wiedenmann B, Berg T. Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues. Hepatology. 2010 Jan;51(1):73-80. doi: 10.1002/hep.23246.
Berg T, Marcellin P, Zoulim F, Moller B, Trinh H, Chan S, Suarez E, Lavocat F, Snow-Lampart A, Frederick D, Sorbel J, Borroto-Esoda K, Oldach D, Rousseau F. Tenofovir is effective alone or with emtricitabine in adefovir-treated patients with chronic-hepatitis B virus infection. Gastroenterology. 2010 Oct;139(4):1207-17. doi: 10.1053/j.gastro.2010.06.053. Epub 2010 Jun 20.
Other Identifiers
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GS-US-174-0106
Identifier Type: -
Identifier Source: org_study_id