|
ISRCTN
|
ISRCTN78766104
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Comparison of intermediate and high dose valaciclovir for the prophylaxis of CMV viraemia in allogeneic stem cell transplant recipients
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0256114044
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Infections and Infestations: Cytomegalovirus (CMV) infection
|
|
Participants - inclusion criteria
|
110 Patients, 55 in each treatment arm.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
03/07/2002
|
|
Anticipated end date
|
01/07/2004
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
110
|
|
Interventions
|
Randomised controlled trial.
|
|
Primary outcome measure(s)
|
Rate of CMV viraemia, time to CMV viraemia, incidence of CMV disease and survival.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
The Royal Free Hampstead NHS Trust
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Michael
Potter
|
|
Address
|
Department of Haematology
The Royal Free & University Medical School
Pond Street
Hampstead
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW3 2QG
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 020 7830 2300/2301 x5173
|
|
Fax
|
+44 020 7830 2092
|
|
Email
|
m.potter@rfc.ucl.ac.uk
|
|
Sponsor
|
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
12/09/2003
|
|
Last edited
|
21/11/2005
|
|
Date ISRCTN assigned
|
12/09/2003
|