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ISRCTN
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ISRCTN52566041
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0060110647
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Study hypothesis
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In treating chronic HCV patients who failed to respond to standard interferon X, is the combination of PEG interferon plus ribervirin plus mycophenolate better than PEG plus ribavirin?
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Infections and Infestations: Hepatitis C
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Participants - inclusion criteria
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60 patients in each arm - 15-25 from C&W.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/04/2002
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Anticipated end date
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01/04/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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60
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Interventions
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Randomised, prospective trial.
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Primary outcome measure(s)
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Sustained response 24-28 weeks post completion of therapy.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Chelsea and Westminster Healthcare NHS Trust
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Trial website
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Publications
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Contact name
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Dr
David
Westaby
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Address
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Gastroenterology Dept
4th Floor, Management 3
Chelsea and Westminster Hospital
369 Fulham Road
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City/town
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London
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Zip/Postcode
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SW10 9NH
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Country
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United Kingdom
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Tel
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+44 (0) 20 8746 1076
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Fax
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x8100
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Email
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karen.hawkins@chelwest.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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21/11/2005
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Date ISRCTN assigned
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30/09/2004
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