Chronic Hepatitis B MedDRA version: 17.1 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female • 2 years to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant or lactating subjects. • Sexually-active males or females of childbearing potential who are not willing to use an effective method of contraception during the study. (see Section 7.7. for further details). • Decompensated liver disease defined as PT > 1.2 × ULN, platelets 50 ng/mL • Evidence of hepatocellular carcinoma (HCC) • Co-infection with HIV, acute HAV, HCV, or HDV • Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, alpha-1 antitrypsin deficiency, cholangitis) • History of significant renal disease (e.g., nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis, acute tubular necrosis, other renal disease) • History of significant bone disease (e.g., 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 • Parenteral aminoglycoside antibiotics (e.g., gentamicin, tobramycin, amikacin) • Cidofovir • Cisplatin • Foscarnet • IV amphotericin B • IV pentamidine • Oral or IV ganciclovir • Cyclosporine • Tacrolimus • IV vancomycin • Chronic daily non-steroidal anti-inflammatory drug therapy • Competitors of renal excretion (e.g., probenecid) • Systemic chemotherapeutic agents • Systemic corticosteroids (pulmonary administration via MDI/nebulizer and oral steroids administered for less that 5 days are permitted) • 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 45 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 subject unsuitable for the study or unable to comply with dosing requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 72;Main Objective: The primary objective of this study is to evaluate the antiviral efficacy of tenofovir DF versus placebo in pediatric patients (aged 2 to < 12 years, at the time of enrollment) with chronic hepatitis B infection;Primary end point(s): The primary efficacy endpoint is the proportion of patients with serum HBV DNA < 400 copies/mL at Week 72 in each arm.;Secondary Objective: To evaluate the proportion of subjects with HBeAg seroconversion at Week 72 (in subjects with baseline HBeAg sero-positivity) To characterize the safety and tolerability profile of tenofovir DF in pediatric patients (aged 2 to < 12 years, at the time of enrollment) with chronic hepatitis B infection To evaluate the biochemical and serological responses to tenofovir DF versus placebo To evaluate the incidence of potential resistance mutations to tenofovir DF in the hepatitis B virus polymerase/reverse transcriptase (pol/RT) To assess the pharmacokinetics of tenofovir in subjects receiving the tablet formulation and those receiving the oral powder formulation | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Weeks 72, 96 and / or 192;Secondary end point(s): The proportion of subjects with HBeAg seroconversion (in subjects with baseline HBeAg sero-positivity only) at Week 72 The proportion of subjects with normal ALT and normalization of ALT The composite endpoint of proportion of subjects with HBV DNA < 400 copies/mL and normal ALT The proportion of subjects with HBV DNA < 169 copies/mL The proportions of subjects with HBsAg loss and seroconversion The genotypic changes from baseline within the HBV polymerase for subjects who were viremic (HBV DNA = 400 copies/mL) at Weeks 72, 144, 192 or Early Discontinuation; with confirmed virologic breakthrough Cumulative incidence of at least a 4% decrease from baseline in bone mineral density of lumbar spine Percent change from baseline in bone mineral density of lumbar spine | — |
Countries
Bulgaria, India, Korea, Republic of, Poland, Romania, Taiwan, United States
Contacts
Public ContactEU Legal Representative for GSI
Gilead Sciences International Ltd
Outcome results
None listed