Condition category
Digestive System
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Arun Shankar

ORCID ID

Contact details

University of Cambridge
Department of Medicine
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7761

Study information

Scientific title

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 measures

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

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

http://www.oncology.cam.ac.uk/research/themes/cctc.html

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes