| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN52566041 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0060110647 |
| Public 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Infections and Infestations: Hepatitis C |
| Study hypothesis | 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? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 60 patients in each arm - 15-25 from C&W. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/04/2002 |
| Anticipated end date | 01/04/2004 |
| Status of trial | Completed |
| Target number of participants | 60 |
| Interventions | Randomised, prospective trial. |
| Primary outcome measure(s) | Sustained response 24-28 weeks post completion of therapy. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Chelsea and Westminster Healthcare NHS Trust |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr David Westaby |
| Contact details | Gastroenterology Dept
4th Floor, Management 3
Chelsea and Westminster Hospital
369 Fulham Road
London
United Kingdom
SW10 9NH |
| Contact telephone | +44 (0) 20 8746 1076 |
| Contact fax | x8100 |
| Contact email | karen.hawkins@chelwest.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN52566041 |
| Date last extracted from ISRCTN register | 17/04/2008 |
