Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0256114044
Study information
Scientific title
Comparison of intermediate and high dose valaciclovir for the prophylaxis of CMV viraemia in allogeneic stem cell transplant recipients
Acronym
Study hypothesis
Does high does valaciclovir four times daily have greater efficacy in reducing CMV viraemia than valaciclovir in allogeneic stem cell recipients?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Infections and Infestations: Cytomegalovirus (CMV) infection
Intervention
Randomised controlled trial.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Rate of CMV viraemia
2. Time to CMV viraemia
3. Incidence of CMV disease
4. Survival
Secondary outcome measures
Not provided at time of registration
Overall trial start date
03/07/2002
Overall trial end date
01/07/2004
Reason abandoned
Eligibility
Participant inclusion criteria
110 patients, 55 in each treatment arm.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
110
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
03/07/2002
Recruitment end date
01/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Royal Free & University Medical School
London
NW3 2QG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Royal Free Hampstead NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary