Chronic Hepatitis B MedDRA version: 18.0 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Gilead Sciences International Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 12 to = 6 months) 3) Weight >= 35 kg 4) Able to swallow oral tablets 5) Subjects must be naïve to Tenofovir DF, but could have received interferon or any oral anti-HBV nucleoside/nucleotide therapy 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
Exclusion criteria: 1)Prior Tenofovir DF therapy; subjects may have received prior interferon or oral anti HBV nucleoside/nucleotide therapy (subjects experienced on interferon must have discontinued therapy for a minimum of six months; treatment-experienced subjects receiving oral anti-HBV nucleoside/nucleotide treatment at screening should continue their current treatment regimen until Tenofovir DF is initiated (i.e., to prevent ALT flare)) 2)Sexually-active males or females of reproductive potential who are not willing to use an effective method of contraception during the study. 3)Females who are pregnant or breastfeeding, or females who wish to become pregnant during the course of the study. 4)Known hypersensitivity to Tenofovir DF, the metabolites or formulation excipients 5)Any 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 treatment requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the long term (i.e., 96 weeks of follow up) bone safety profile of open-label Tenofovir DF treatment in CHB infected adolescents. This includes prospectively evaluating and comparing the bone mineral density (BMD) change between CHB- infected adolescents 12 to < 18 years of age treated with Tenofovir DF in European treatment centers who are assigned to one of two schedules for renal and bone laboratory monitoring and BMD measurement. Primary study outcome will be the percent changes in BMD from Baseline through study Week 96.;Secondary Objective: •To document all serious adverse drug reactions (SADR) and all renal- and bone-related adverse events (AEs), including renal and bone laboratory abnormalities •To determine the time to diagnosis of renal and bone AEs and document the resulting patient management and outcome(s) •To assess the clinical management and outcomes of renal and bone-related = Grade 3 laboratory markers and clinical SAEs •To assess the efficacy and tolerability of Tenofovir DF in adolescents with CHB infection;Primary end point(s): The identification of bone AEs occurring in subjects taking Tenofovir DF between Baseline and Week 96 of treatment, including the identification of =4% percent reduction in BMD within subjects and between monitoring groups from Baseline.;Timepoint(s) of evaluation of this end point: Between baseline to week 96 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Documentation of renal or bone AEs and outcomes among subjects receiving Tenofovir DF, including rates of medication withdrawal or drug discontinuation •Subjects’ cumulative exposure time on Tenofovir DF at the time renal or bone AEs are detected up to and including Week 96 or to study discontinuation (subjects without renal or bone AEs will contribute cumulative exposure time on Tenofovir DF from Baseline to Week 96 or to study discontinuation). The cumulative time to renal or bone AEs will be expressed as incident rates. •Documentation of the medical management and classification of detected renal or bone laboratory abnormalities •Analysis of subjects’ virological and immunological status from Baseline to Week 96 under real world treatment practices ;Timepoint(s) of evaluation of this end point: Between baseline to week 96 | — |
Countries
Belgium, Bulgaria, Greece, Spain, United Kingdom
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd
Outcome results
None listed