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 |
| Protocol serial number | N0060110647 |
| Sponsor | Department of Health |
| Funder | Chelsea and Westminster Healthcare NHS Trust (UK) |
- 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
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 |
|---|---|
| karen.hawkins@chelwest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Sustained response 24-28 weeks post completion of therapy |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Chelsea and Westminster Hospital
London
SW10 9NH
United Kingdom
SW10 9NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
