Tenofovir DF in Adolescent CHB
Research type
Research Study
Full 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
IRAS ID
174166
Contact name
Sanjay Bansal
Contact email
Sponsor organisation
Gilead Sciences International Ltd.
Eudract number
2014-004939-39
Duration of Study in the UK
4 years, 0 months, 23 days
Research summary
Hepatitis B is an infectious disease, caused by the hepatitis B virus (HBV) that primarily affects the liver. Chronic infection can cause liver damage, called cirrhosis, which left unchecked can lead to liver failure or liver cancer.
Tenofovir disoproxil fumerate (tenofovir DF or Viread) has been approved by the European Commission for the treatment to chronic HBV in adolescents aged 12 years old to less than 18 years old. Clinical studies have shown that the use of Viread may lower the amount of HBV in the patients’ body and may improve the condition of their liver.
Decreases in bone mineral density have been seen in patients receiving Viread. It is not known if the changes in bone mineral density observed in DXA scan results may have an impact on the health of patients. The risk of bone fracture associated with these types of changes is unknown.
This study is to define what the long term effects on the patients’ bone mineral density are in chronic HBV infected adolescents taking Viread.
Approximately 100 male and female adolescents aged 12 to under 16 will be enrolled at 25 centres across Europe. Participation in the study will last just under 2 years.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
15/NE/0170
Date of REC Opinion
25 Jun 2015
REC opinion
Further Information Favourable Opinion