Clinical trial NCT02479880: Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatitis B
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (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.


Eligibility criteria: Key Inclusion Criteria:

1. 12 to \<16 years of age
2. Documented chronic hepatitis B virus (HBV) infection
3. Weight ≥ 35 kg
4. Able to swallow oral tablets
5. Negative pregnancy test for females of childbearing potential
6. Adequate kidney (renal) function
7. Parent or legal guardian of potential study subjects able to provide written informed consent

Key Exclusion Criteria:

1. Previously received tenofovir DF
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

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants With Bone-Related Adverse Events and/or a ≥ 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96
timeFrame: Baseline to Week 96
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaries Saint- Luc, Departem Pediatrie
city: Bron
country: France
facility: Hopital Femmes Meres Enfants
city: Chaidari
country: Greece
facility: Attikon General Hospital Of Athens
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna
city: Bucharest
country: Romania
facility: Grigore Alexandrescu Childrens Emergency Clinical Hospital
city: Constanta
country: Romania
facility: Spitatul Clinic de Boli Infectioase Constanta
city: Iaşi
country: Romania
facility: Institutul de Gastrenterologie si Hepatologie Iasi
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
city: Vigo
country: Spain
facility: Hospital de Meixoeiro
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital NHS Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: