A Study of Entecavir in Children with Chronic Hepatitis B Infection

• Research type

  Research Study

• Full title

  A Comparative Study of the Antiviral Efficacy and Safety of Entecavir (ETV) versus Placebo in Paediatric Subjects with Chronic Hepatitis B Virus (HBV) Infection who are HBeAg-Positive.

• IRAS ID

  44091

• Contact name

  Deirdre Anne Kelly

• Sponsor organisation

  Bristol Myers Squibb International Corporation

• Eudract number

  2009-016357-17

• Clinicaltrials.gov Identifier

  NCT01079806

• Research summary

  Currently there are several treatment options available for adults with Chronic Hepatitis B (CHB), however there are fewer treatment options for paediatric patients with CHB. In the USA there are 3 drugs approved for the treatment of CHB in children, and in Europe no drug has been approved. Entecavir is approved to treat adults with CHB and has an established safety and tolerability profile, however there is little information about the use of this drug in children and adolescents. The purpose of this study is to assess the safety and efficacy of Entecavir (tablet or liquid) in children and adolescents aged 2-17 years with CHB, who are HBeAg-positive. Of the 180 study subjects to be treated worldwide, two thirds will receive Entecavir and one third will receive placebo (dummy drug). The first part of the study is the treatment phase (about 2 to 3 « years) Blood tests performed during this phase will help determine how study subjects immunity is controlling the virus. If after approximately one year on study, these tests fail to show adequate immunologic control of the virus, subjects will be given Entecavir, regardless of the treatment they were taking initially, therefore all study subjects have the possibility to receive Entecavir based on their blood results. How long subjects receive study medication is determined by how well they are responding. Following the treatment phase, subjects will go into the follow-up phase. The duration of subjects study participation will be 5 years. The study is funded by Bristol Myers Squibb.UK recruitment is scheduled to start in May 2011 and will end in 2017 and is being carried out in London and Birmingham. Subjects who consent to taking part in this study will undergo blood tests and physical examinations throughout the study.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  11/H1308/5

• Date of REC Opinion

  28 Mar 2011

• REC opinion

  Further Information Favourable Opinion