Assessment of Intrahepatic Hepatitis C Virus (HCV) RNA Levels at the Time

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to measure intrahepatic HCV RNA levels at the time of liver transplantation in patients receiving antiviral therapy while on the liver transplant waiting list. This will eventually be correlated with the degree of hepatic fibrosis present within different geographic sites in the cirrhotic liver. Tissue samples will be obtained from the patient's liver explant as well as hilar lymph nodes. Upon the removal of the cirrhotic liver at the time of transplantation, the explant will be biopsied multiple times in different segments of the liver and preserved for viral detection studies as well as analysis of the degree of fibrosis. Peripheral blood mononuclear cells (PBMCs) will be obtained for viral detection at the time of transplantation. Serum HCV RNA levels will also be obtained at 1 month, 3 months and 6 months post liver transplantation.

Study Hypotheses:

- Virological relapse or non-response is higher is patients with cirrhosis due to failure of antiviral medication to concentrate adequately in a fibrotic liver having an altered sinusoidal micro-architecture

- HCV may persist in different geographic regions of the fibrotic liver in part predicated on blood supply to that area and this may have an effect on overall virological response. These differences in viral persistence and detection may exist in different lobes of the liver or even within a few centimeters within the same portion of the liver parenchyma.

- PBMC and hilar lymph nodes may be extrahepatic reservoirs of HCV viral persistence in patients receiving antiviral therapy and may account for virological relapse post-therapy

- There may be varying degrees of fibrosis within the same cirrhotic liver which may impact on hepatic synthetic function and antiviral response to treatment.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01836718
Study type	Observational
Source	Schiano, Thomas D., MD
Contact
Status	Active, not recruiting
Phase	N/A
Start date	June 2013
Completion date	June 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04180735` - Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital
Completed	`NCT01011205` - Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation	Phase 3
Completed	`NCT01888432` - Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants	Phase 3
Recruiting	`NCT04203004` - HOPE With Cytokine Filtration in Liver Transplantation (Cyto-HOPE)	N/A
Recruiting	`NCT04564313` - Safety and Efficacy of Camrelizumab (Anti-PD-1 Antibody) in Recurrent HCC After Liver Transplantation	Phase 1
Withdrawn	`NCT03596970` - Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.	Phase 3
Not yet recruiting	`NCT02544906` - Propofol Versus Dexmedetomidine for Prevention of Sevoflurane Agitation in Recipients of Living Donor Liver Transplantation	N/A
Completed	`NCT03133065` - Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs	Phase 4
Recruiting	`NCT01705015` - Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement	N/A
Completed	`NCT01425385` - Autoregulation Assessment During Liver Transplantation	N/A
Terminated	`NCT01445236` - Pilot Study of Immunosuppression Drug Weaning in Liver Recipients Exhibiting Biomarkers of High Likelihood of Tolerance	N/A
Completed	`NCT01655563` - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation	Phase 2
Completed	`NCT00938860` - Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C	Phase 4
Completed	`NCT00531921` - Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival	N/A
Terminated	`NCT00585858` - Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant	N/A
Completed	`NCT00456235` - Reduction in the Risk of Rejection by Mycophenolate Mofetil Dose Adjustment in Liver Transplant Patients With Side Effects Caused by the Calcineurine Inhibitors	Phase 4
Withdrawn	`NCT00585429` - Evaluation of Kidney Disease in Liver Transplant Recipients	N/A
Recruiting	`NCT00147459` - Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation	N/A
Withdrawn	`NCT00167492` - Enteric Coated Myfortic for Liver Transplant Recipients	Phase 4
Terminated	`NCT00161356` - Ambisome in Liver Transplant Patients	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Assessment of Intrahepatic Hepatitis C Virus (HCV) RNA Levels at the Time of Liver Transplantation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms