Ensayo Clínico aleatorizado, doble ciego, comparado con placebo, para evaluar la eficacia, seguridad y tolerabilidad de Tenofovir Disoproxil Fumarato en adolescentes infectados por la Hepatitis B crónicaA Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Adolescents with Chronic Hepatitis B Infectio

Phase 1

• Conditions: Hepatitis B crónicaChronic hepatitis B; MedDRA version: 9.1Level: LLTClassification code 10008910Term: Chronic hepatitis B

• Registration Number: EUCTR2007-003704-35-ES
• Lead Sponsor: Gilead Science Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-22
• Study Completion: 2015-12-02
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Male or female
• 12 through 17 years of age, inclusive (consent of parent/legal guardian required)
• Documented chronic HBV infection, defined as positive serum HBsAg = 6 months
• HBeAg positive
• Weight = 35 kg
• Able to swallow oral tablets
• HBV DNA =10^5 copies/mL (PCR method)
• ALT = 2 × ULN at screening, OR any history of ALT = 2 × ULN over the past = 24 months
• Willing and able to provide written informed consent/assent (child and parent/legal guardian)
• Negative serum ß HCG pregnancy test (for post-menarchal females only)
• Estimated glomerular filtration rate (creatinine clearance) = 80 mL/min/1.73m2
• Adequate hematologic function (absolute neutrophil count = 1,500/mm3; hemoglobin = 10.0 g/dL)
• No prior tenofovir DF therapy (subjects may have received prior interferon or oral anti-HBV nucleoside/nucleotide therapy; subjects must have discontinued interferon therapy = 6 months prior to screening; subjects experienced on 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:
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 women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
• Sexually-active 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 < 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, HCV, or HDV
• 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
- Chronic daily non-steroidal anti-inflammatory drug therapy
Administration of any of the above medications must be discontinued at least 30 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