Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7761
Study information
Scientific title
A multi-centre prospective controlled trial comparing calcineurin inhibitor monotherapy with sirolimus monthotherapy in hepatitis C infected patients with hepatic fibrosis following liver transplantation
Acronym
Sirolimus and Hepatitis C following Liver Transplantation V1
Study hypothesis
We hypothesise that in patients who have had liver transplants for Hepatitis C and have damage in their liver graft secondary to Hepatitis C will have this damage slowed by changing from their standard immunosuppressive regime to the drug sirolimus. This study will test this hypothesis.
Ethics approval
MREC approved (ref: 03/H0304/92)
Study design
Multicentre randomised observational treatment cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Hepatology
Intervention
Sirolimus, Change from Standard Immunosupression to Sirolimus
Intervention type
Drug
Phase
Phase IV
Drug names
Sirolimus
Primary outcome measure
Liver Biopsy Fibrosis Score
Secondary outcome measures
1. Diabetic status
2. Renal function
3. Cardiovascular risk index
Overall trial start date
01/05/2010
Overall trial end date
01/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 120
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2010
Recruitment end date
01/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Cambridge
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Addenbrooke's Hospital (UK)
Sponsor details
Cambridge Cancer Trials Office
Oncology Centre
Box No 193
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Wyeth Pharmaceuticals (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