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

ISRCTN	ISRCTN52566041
DOI	https://doi.org/10.1186/ISRCTN52566041
Secondary identifying numbers	N0060110647

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 30/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Westaby
Scientific

Gastroenterology Dept
4th Floor, Management 3
Chelsea and Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

Phone	+44 (0) 20 8746 1076
Email	karen.hawkins@chelwest.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Hepatitis C
Intervention	Randomised, prospective trial.
Intervention type	Other
Primary outcome measure	Sustained response 24-28 weeks post completion of therapy
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/2002
Completion date	01/04/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Key inclusion criteria	60 patients in each arm - 15-25 from Chelsea and Westminster NHS Trust
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2002
Date of final enrolment	01/04/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Chelsea and Westminster Hospital

London
SW10 9NH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Hospital/treatment centre

Chelsea and Westminster Healthcare NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

30/04/2018: No publications found, verifying study status with principal investigator.
10/03/2016: No publications found, verifying study status with principal investigator