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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list