Condition category
Infections and Infestations
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Potter

ORCID ID

Contact details

Department of Haematology
The Royal Free & University Medical School
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

30/11/2015: no publications found on PubMed.