Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB
Condition: Hepatitis B Virus
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Telbivudine; Tenofovir; Telbivudine plus tenofovir
Intervention description: 600 mg monotherapy supplied in film-coated tablets.; Tenofovir disoproxil fumarate was supplied in 300 mg tablets; Telbivudine 600 mg and Tenofovir 300 mg were purchased in commercial packs. Patients were instructed to take medication(s) orally every morning either with or without food.
Intervention MeSH terms: Tenofovir; Telbivudine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Chronic HBV; Asian adult subjects with chronic HBV, in immune tolerant phase, and positive for hepatitis B e antigen (HBeAg)

Summary:

      The purpose of this study is to compare the safety, tolerability and effectiveness of 12
      weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD)
      taken together vs. tenofovir DF 300 mg once daily (QD) or vs telbivudine 600 mg monotherapy
      daily (QD). This is an open labeled, active controlled, viral kinetics study which means the
      subjects and study doctor will know what study drug subjects have been assigned. This study
      is open to male and female subjects, <40 years of age, who have been infected with HBV for at
      least 6 months and have not received oral treatment for HBV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic HBV infection, defined as positive serum HBsAg for at least 6 months, or HBsAg
             positive > 3 months and negative for IgM anti-HBc and positive for IgG anti-HBc

          -  Age < 40 years old

          -  HBeAg positive

          -  HBV DNA > or = to 10^7 copies/mL by Abbott real-time PCR

          -  ALT < or = to 1 ULN

          -  Willing and able to provide written informed consent

          -  No prior oral HBV therapy (e.g., nucleotide and/or nucleoside therapy or other
             investigational agents for HBV infection)

          -  Is willing and able to comply with the study drug regimen and all other study
             procedures and requirements

          -  Is willing and able to provide written informed consent before any study assessment is
             perform

        Exclusion Criteria:

          -  Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 × ULN, PT >
             1.2 × ULN, platelets < 150,000/mm3, serum albumin < 3.5 g/dL, or prior history of
             clinical hepatic decompensation (e.g. ascites, jaundice, encephalopathy, variceal
             hemorrhage).

          -  Received interferon (pegylated or not) therapy within 6 months of the screening visit

          -  α-fetoprotein > 50 ng/mL

          -  Evidence of hepatocellular carcinoma (HCC)

          -  Co-infection with HCV (by serology), or HIV,

          -  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 susceptible of modifying renal
             excretion.

          -  Has proximal tubulopathy.

          -  Use of other investigational drugs at the time of enrollment, or within 30 days

          -  History of hypersensitivity to any of the study drugs or to drugs of similar chemical
             classes

          -  Is pregnant or breastfeeding.

          -  Is a women of child-bearing potential (WOCBP)unless post-menopausal or using one or
             more acceptable method of contraception.

          -  Patient has any other concurrent medical or social condition likely to preclude
             compliance with the schedule of evaluations in the protocol, or likely to confound the
             efficacy or safety observations of the study.

          -  Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol
             abuse or illicit substance abuse within the preceding two years.

          -  Patient has a medical condition that requires prolonged or frequent use of systemic
             acyclovir or famciclovir.

        Other protocol-defined inclusion/exclusion criteria may apply