Phase 4
N=11
Study of Sirolimus Versus Mycophenolate Liver Transplant Recipients With Recurrent Hepatitis C Virus (HCV)
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT01134952 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Delta Hepatitis C Viral Load — 15 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mycophenolate to sirolimus switch (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- London Health Sciences Centre
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delta Hepatitis C Viral Load |
15 | — |
| SECONDARY Final Hepatitis C Viral Load |
-47 | — |
| SECONDARY Sirolimus Trough Level |
7.2 | — |
| SECONDARY Delta Tacrolimus Trough Level |
23 | — |
| SECONDARY Delta Bilirubin |
-6.0 | — |
| SECONDARY Delta Alkaline Phosphatase |
13.8 | — |
| SECONDARY Delta Alanine Aminotransferase |
9 | — |
| SECONDARY Delta Hemoglobin |
-2.7 | — |
| SECONDARY Delta Platelet Count |
-8.5 | — |
| SECONDARY Delta Cholesterol Fasting Level |
1.2 | — |
| SECONDARY Delta Triglyceride Fasting Level |
23 | — |
Summary
Different immunosuppressive drugs used in transplantation may reduce the body's defences against infection differently. It is known that patients with Hepatitis C virus, known as HCV, who switched from azathioprine to mycophenolate mofetil experienced an increase in viral load. Despite this, mycophenolate mofetil is used because it prevents rejection more reliably than azathioprine. Sirolimus is an another immunosuppressive agent that reliably prevents rejection and may have antiviral activity. This study is designed to see if the viral load of HCV and other viruses is reduced by switching from mycophenolate to sirolimus.
Eligibility Criteria
Inclusion Criteria
- Recurrent HCV after liver transplantation
- Taking mycophenolate mofetil
- Stable liver function
Exclusion Criteria
- Pregnant females or couples unwilling to use contraception
- Intolerance or allergy to sirolimus
- Patients taking anti-HCV therapy
- Patients taking medications known to alter the levels of sirolimus
- History of thromboembolic disease
Data sourced from ClinicalTrials.gov (NCT01134952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.