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 |
| Protocol serial number | 7761 |
| Sponsor | Addenbrooke's Hospital (UK) |
| Funder | Wyeth Pharmaceuticals (UK) |
- 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
| Primary study design | Observational |
|---|---|
| Study design | Multicentre randomised observational treatment cohort study |
| Secondary study design | Cohort study |
| 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 |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Sirolimus |
| Primary outcome measure(s) |
Liver Biopsy Fibrosis Score |
| Key secondary outcome measure(s) |
1. Diabetic status |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
University of Cambridge
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
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 |
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
