Treatment of HBeAg positive chronic hepatitis B (CHB) in children.

• Research type

  Research Study

• Full title

  A phase IIIb parallel group, open label study of pegylated interferon alfa-2a monotherapy (PEG-IFN, Ro 25-8310) compared to untreated control in children with HBeAg positive chronic hepatitis B.

• IRAS ID

  83735

• Contact name

  Giorgina Mieli-Vergani

• Sponsor organisation

  Roche

• Eudract number

  2011-002732-70

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is being carried out to find out whether PEG-IFN (pegylated interferon Alfa-2a) monotherapy is safe and effective in treating HBeAg positive children with Chronic Hepatitis B virus infection compared with those in an untreated control group. The study is a randomized controlled trial with 3 treatment groups. Children without advanced fibrosis/cirrhosis will be randomised 2:1 to treatment (Gp A) or no treatment (Gp B) respectively. Those with advanced fibrosis will be assigned to Gp C (active treatment). The study comprises a 48 week treatment period (Gp A&C) or observation (Gp B) followed by 24 weeks f/up at which point the primary endpoint will be assessed. Following this the children will be followed up for an extra 4.5 years. Children in groups A&C will be in the study for a total of 6 years. 48 weeks after randomization, Gp B will be offered PEG-IFN treatment in a switch arm, providing they have not experienced HBeAg seroconversion. This option is open for up to one year following week 48. They will then follow the 48 week treatment schedule and follow up periods. Children in group B who switch could be in the study for up to 8 years. Recruitment is planned to be completed in July 2013. Children should be aged 3 to 17 years.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  11/SC/0454

• Date of REC Opinion

  9 Feb 2012

• REC opinion

  Further Information Favourable Opinion