Chronic Hepatitis B MedDRA version: 9.1 Level: LLT Classification code 10008910 Term: Chronic hepatitis B
Conditions
Interventions
Trade Name: Viread
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tenofovir disoproxil fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Sponsors
Gilead Sciences Incorporated
Eligibility
Sex/Gender
All
Inclusion 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 •18 through 69 years of age, inclusive •HBeAg positive or negative •HBV DNA = 108 copies/mL •ALT = ULN •Willing and able to provide written informed consent •Negative serum ß HCG (for females of childbearing potential only) •Calculated creatinine clearance = 70 mL/min by the following formula: (140-age in years) (body weight [kg]) (72) (serum creatinine [mg/dl]) [Note: multiply estimated rate by 0.85 for women] •Hemoglobin = 10 g/dL •Neutrophils = 1,500 /mm3 •No prior oral HBV therapy (e.g., nucleotide and/or nucleoside therapy or other investigational agents for HBV infection). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study. •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, PT > 1.2 x ULN, platelets 50 ng/mL •Evidence of hepatocellular carcinoma (HCC) •Co infection with HCV (by 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 susceptible of modifying renal excretion. •Has proximal tubulopathy. •Known hypersensitivity to the study drugs, the metabolites or formulation excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To compare the antiviral efficacy against hepatitis B virus (HBV) of tenofovir DF monotherapy versus tenofovir DF plus emtricitabine combination therapy ;Secondary Objective: •To evaluate the safety and tolerability of tenofovir DF versus tenofovir DF plus emtricitabine combination therapy •To evaluate the biochemical and serological response to tenofovir DF monotherapy versus tenofovir DF plus emtricitabine combination therapy •To compare the incidence of drug resistant mutations between treatment arms ;Primary end point(s): •To compare the antiviral efficacy against hepatitis B virus of tenofovir DF monotherapy versus tenofovir DF plus emtricitabine combination therapy | — |
Countries
France, Germany, United Kingdom
Outcome results
None listed