A multi-centre prospective controlled trial comparing calcineurin inhibitor monotherapy with sirolimus monthotherapy in hepatitis C infected patients with hepatic fibrosis following liver transplantation
| ISRCTN | ISRCTN26350966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26350966 |
| Secondary identifying numbers | 7761 |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 18/01/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
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 Arun Shankar
Scientific
Scientific
University of Cambridge
Department of Medicine
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Multicentre randomised observational treatment cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 |
| Study acronym | Sirolimus and Hepatitis C following Liver Transplantation V1 |
| Study objectives | 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(s) | MREC approved (ref: 03/H0304/92) |
| Health condition(s) or problem(s) studied | Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Hepatology |
| Intervention | Sirolimus, Change from Standard Immunosupression to Sirolimus |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Sirolimus |
| Primary outcome measure | Liver Biopsy Fibrosis Score |
| Secondary outcome measures | 1. Diabetic status 2. Renal function 3. Cardiovascular risk index |
| Overall study start date | 01/05/2010 |
| Completion date | 01/12/2013 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Planned sample size: 120 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 01/12/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Cambridge
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Addenbrooke's Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Cambridge Cancer Trials Office
Oncology Centre, Box No 193
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom
| Website | http://www.oncology.cam.ac.uk/research/themes/cctc.html |
|---|---|
"ROR" |
https://ror.org/055vbxf86 |
Funders
Funder type
Industry
Wyeth Pharmaceuticals (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
18/01/2019: This trial never started as by the time the trialists were ready to recruit, a new antiviral therapy was on the market that made the question of this trial irrelevant.
15/03/2017: No publications found in PubMed, verifying study status with principal investigator
