Condition category
Infections and Infestations
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
10/03/2016
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 David Westaby

ORCID ID

Contact details

Gastroenterology Dept
4th Floor
Management 3
Chelsea and Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
+44 (0) 20 8746 1076
karen.hawkins@chelwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0060110647

Study information

Scientific title

40kD pegylated interferon alpha 2a plus ribavirin compared to 40 kD pegylated interferon alpha 2a plus ribavirin and mycophenolate in the management of patients with refractory chronic HCV infection

Acronym

Study hypothesis

In treating chronic HCV patients who failed to respond to standard interferon X, is the combination of PEG interferon plus ribavirin plus mycophenolate better than PEG plus ribavirin?

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

Hepatitis C

Intervention

Randomised, prospective trial.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Sustained response 24-28 weeks post completion of therapy

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2002

Overall trial end date

01/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

60 patients in each arm - 15-25 from Chelsea and Westminster NHS Trust

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2002

Recruitment end date

01/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Chelsea and Westminster Hospital
London
SW10 9NH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Chelsea and Westminster Healthcare 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

10/03/2016: No publications found, verifying study status with principal investigator