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Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil
This study is ongoing, but not recruiting participants.
Sponsored by: Gilead Sciences
Information provided by: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00307489
  Purpose

This study will explore the efficacy, safety and tolerability of tenofovir DF 300 mg monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg in subjects currently being treated with adefovir dipivoxil (Hepsera) for chronic hepatitis B who have persistent viral replication (detectable HBV DNA).


Condition Intervention Phase
Chronic Hepatitis B
Drug: tenofovir DF
Drug: emtricitabine /tenofovir DF
Phase II

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Hepatitis B Vaccines Adefovir dipivoxil Adefovir Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 2, Randomized, Double-Blind Study Exploring the Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects Currently Being Treated With Adefovir Dipivoxil for Chronic Hepatitis B and Having Persistent Viral Replication

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • proportion of subjects with plasma HBV DNA < 169 copies/mL [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: March 2006
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: tenofovir DF
    300 mg tablet, once daily
    Drug: emtricitabine /tenofovir DF
    emtricitabine 200 mg/tenofovir DF 300 mg once daily (combination tablet)
  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 through 69 years of age, inclusive
  • 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 72 weeks)
    2. HBeAg positive or negative at screening
    3. Serum HBV DNA greater than 100,000 copies/mL for HBe Ag positive OR serum HBV DNA greater than 10,000 copies/mL for HBe Ag negative at screening
    4. Serum ALT less than 10 times the upper limit of normal
    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-naïve or lamivudine-experienced
  • Negative serum beta-HCG
  • Compliant with adefovir dipivoxil
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
  • 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 (e.g., 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 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), HIV, or HDV.
  • Significant renal, cardiovascular, pulmonary, or neurological disease.
  • Received solid organ or bone marrow transplantation.
  • Is currently receiving therapy with immunomodulators (e.g., 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307489

Locations
United States, New York
Flushing, New York, United States, 11355
United States, Virginia
Fairfax, Virginia, United States, 22031
Norfolk, Virginia, United States, 23502
France
Angers, France, 49933
Marseille, France, 13285
Paris, France, 75013
Strasbourg, France, 67090
Clichy, France, 92110
Lille, France, 59037
Rouen, France, 76031
Lyon, France, 69288
Germany
Berlin, Germany, 13353
Herne, Germany, 44623
Erlangen, Germany, 91054
Munchen, Germany, 81377
Berlin, Germany, 10969
Frankfurt, Germany, 60590
Bonn, Germany, 53105
Hamburg, Germany, 20246
Spain
Sevilla, Spain, 41014
Granada, Spain, 18014
Malaga, Spain, 29010
Granada, Spain, 18012
Barcelona, Spain, 08003
Sevilla, Spain, 41013
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Chair: David Oldach, MD Gilead Sciences
  More Information

Responsible Party: Charite Campus Virchow-Klinikum ( Thomas Berg )
Study ID Numbers: GS-US-174-0106
Study First Received: March 24, 2006
Last Updated: October 3, 2008
ClinicalTrials.gov Identifier: NCT00307489  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Emtricitabine
Hepatitis B, Chronic
Hepatitis B
Tenofovir
DNA Virus Infections
Adefovir dipivoxil
Viremia
Adefovir
Tenofovir disoproxil

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009