Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02479880
• Other study ID #: GS-EU-174-1403
• Secondary ID: 2014-004939-39
• Status: Terminated
• Phase: Phase 4
• Start date: July 3, 2015
• Est. completion date: April 11, 2018

Study information

• Verified date: February 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: April 11, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Tenofovir DF
300 mg tablet administered orally once daily for up to 96 weeks

Radiation:
• DEXA Scan
Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points

Locations

Country	Name	City	State
Belgium	Cliniques Universitaries Saint- Luc, Departem Pediatrie	Brussels
France	Hopital Femmes Meres Enfants	Bron
Greece	Attikon General Hospital Of Athens	Chaidari
Italy	Azienda Ospedaliero-Universitaria di Bologna	Bologna
Romania	Grigore Alexandrescu Childrens Emergency Clinical Hospital	Bucharest
Romania	Spitatul Clinic de Boli Infectioase Constanta	Constanta
Romania	Institutul de Gastrenterologie si Hepatologie Iasi	Iasi
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Sant Joan de Déu	Barcelona
Spain	Hospital de Meixoeiro	Vigo
United Kingdom	Birmingham Children's Hospital NHS Trust	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

Belgium,  France,  Greece,  Italy,  Romania,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Bone-Related Adverse Events and/or a = 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96		Baseline to Week 96