A study in children with long-lasting Hepatitis B infection to assess the effectiveness and safety of the drug Viread

• Conditions: Chronic Hepatitis B; MedDRA version: 14.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-000586-20-PL
• Lead Sponsor: Gilead Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-27
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Male or female
• 2 years to < 12 years of age (consent of parent or legal guardian required)
• Body weigh = 10kg
• Documented chronic HBV infection, defined as positive serum HBsAg = 6 months
• HBeAg-positive or HBeAg-negative
• HBV DNA = 105 copies/mL (PCR method)
• ALT = 1.5 × ULN at screening,
• Estimated glomerular filtration rate (creatinine clearance) = 80 mL/min/1.73m2
-Estimated creatinine clearance using Schwartz Formula (mL/min/1.73m2) = k × L/Scr
-[(k is a proportionality constant: pediatric males/females = 2 years to < 12 years
k = 0.55; for adolescent females = 12 years old, k = 0.55, and for adolescent males = 12 years, k = 0.70); L is height in centimeters (cm); and Scr is serum
creatinine (mg/dL)]
• Adequate hematologic function (absolute neutrophil count = 1,500/mm3; hemoglobin = 10.0 g/dL)
• Negative serum ß-HCG pregnancy test (for females of childbearing potential only)
• Male and female subjects of childbearing potential (defined in section 7.7.1) identified as choosing to become sexually active must agree to utilize highly effective contraception methods or agree to abstain from heterosexual intercourse while on study treatment and for 30 days following the last dose of study drugs; highly effective methods normally utilize two separate forms of contraception, one of which must be an effective barrier contraceptive method.
• Parent or legal guardian able to provide written informed consent prior to any screening
evaluations and willing to comply with study requirements
• Subject able to provide written assent as determined by IRB/IEC/local requirements and Investigator's discretion
• No prior tenofovir DF therapy (subjects may have received prior interferon-alfa and/or other oral anti-HBV nucleoside/nucleotide therapy; subjects must have discontinued interferon-alfa therapy = 6 months prior to screening; subjects experienced on other anti-
HBV nucleoside/nucleotide therapy must have discontinued therapy = 16 weeks prior to screening to avoid flare if randomized to the placebo arm)
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 < 150,000/mm3, serum albumin < 3.5 g/dL, or prior history of clinical hepatic decompensation (e.g., ascites,jaundice, encephalopathy, variceal hemorrhage).
• Receipt of interferon (pegylated or not) therapy within 6 months of the Screening Visit
• Receipt of anti-HBV nucleoside/nucleotide therapy within 16 weeks of the Screening
Visit
• a-fetoprotein > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified