Pharmacoepidemiology study to define the long-term safety profile of tenofovir disoproxil fumarate (Tenofovir DF, Viread®) and describe the management of Tenofovir DF-associated renal and bone toxicity in Chronic Hepatitis B (CHB)-infected adolescents aged 12 to <18 years in Europe

Phase 1

• Conditions: Chronic Hepatitis B; MedDRA version: 18.0Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-004939-39-GB
• Lead Sponsor: Gilead Sciences International Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-09
• Study Completion: 2018-04-11
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) 12 to <16 years of age
2) Documented chronic HBV infection (e.g. positive serum HBsAg >= 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

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

Study & Design

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