CASG 112. Protocol Version: 3.0 Date: 12 DECEMBER 2007

• Research type

  Research Study

• Full title

  A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED , BLINDED INVESTIGATION OF SIX WEEKS VS SIX MONTHS OF ORAL VALGANCICLOVIR THERAPY IN INFANTS WITH SYMPTOMATIC CONGENITAL CYTOMEGALOVIRUS INFECTION (CASG 112)

• IRAS ID

  3920

• Contact name

  Paul D Griffiths

• Sponsor organisation

  University College London (UCL)

• Eudract number

  2008-005508-14

• Clinicaltrials.gov Identifier

  NCT00466817

• Research summary

  This study is a multinational study being conducted in the United States and United Kingdom, looking at whether 6 months antiviral treatment (medicine that kills virus) is better than 6 weeks in infants with congenital cytomegalovirus (CMV). ‘Congenital ’means that infection has occurred before birth. Congenital CMV can cause a wide range of health problems and disabilities and is a leading cause of hearing loss (10-30% of all sensorineural hearing loss) in the developed world. At present the standard treatment for Congenital CMV is with a drug called ganciclovir. This drug is given IV (through the vein), and usually can only be given in hospital. It is usually only given to the most severely affected babies who already have signs of neurological involvement. A previous study showed that infants receiving 6 weeks of treatment with IV ganciclovir had less hearing loss at 6 months and one year than babies who did not receive the drug. These babies also had more side effects though, in particular a decrease in white blood cells (which fight infection), compared to those receiving no medication. A new drug, called valganciclovir, can be taken in liquid form by mouth. Once absorbed from the stomach it turns into ganciclovir in the bloodstream. In this study any babies with symptoms of congenital CMV (not just the most severely affected) will receive six weeks of oral valganciclovir solution. At the end of this period, the babies will be put into groups randomly to either complete a total of six months treatment with oral valganciclovir, or a matching placebo (dummy treatment which looks like medicine but contains no active ingredient). Hearing, growth and neurological development along with side effects associated with the drug will be followed up for 2 years with long-term safety monitoring continuing for a further 3 years.

• REC name

  London - Central Research Ethics Committee

• REC reference

  08/H0718/63

• Date of REC Opinion

  10 Nov 2008

• REC opinion

  Further Information Favourable Opinion