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Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection

Primary Purpose

End Stage Liver Disease, Hepatitis C

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Daclizumub
Tacrolimus
Cyclosporine
MMF
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Liver Disease focused on measuring Hepatitis C Virus, Immunosuppressive Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures for the full 2 years. Patient is a recipient of a primary whole/split, cadaveric/living donor liver transplant for end stage chronic Hepatitis C. Patient is > age 18. Female patients of child bearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion. Exclusion Criteria: Patient has previously received or is receiving an organ transplant other than a liver. Patient has received a liver transplant from a Hepatitis B core antibody or a Hepatitis C antibody positive donor. Patient has received an ABO (blood group anti A, anti B antibodies) incompatible donor liver. Patient has fulminant liver failure with a life expectancy without a liver transplant of less than 7 days as defined by UNOS (Adult Patient Status 1, UNOS Policy 3.6.4.1: See Appendix C). Patient has renal dysfunction pre-transplant that, in the opinion of the investigator, will prohibit the use of calcineurin inhibitors within 72 hours post transplant. Patient is intubated, on vasopressors, is ICU bound, or has experienced a significant blood loss (greater than 5 units) 72 hours prior to transplant procedure. Recipient or donor is seropositive for human immunodeficiency virus (HIV) or HbsAg positive serology. Patient is to receive antilymphocyte antibody induction therapy, such as ATGAM (lymphocyte immune globulin), OKT3 (muromonab-CD3), Simulect (basiliximab), or Thymoglobulin. Patient has a known hypersensitivity to Prograf (TAC), HCO-60, CellCept (MMF), Zenapax or corticosteroids. Patient is pregnant or lactating. Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment. Patient has participated in a trial involving a market drug within 30 days. However, patients who participated in any interferon or ribavirin trials are permitted.

Sites / Locations

  • Baylor Regional Transplant Institute - Baylor University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

tacrolimus and cyclosporine

MMF, tacrolimus and cyclosporine

daclizumub, MMFand tacrolimus

Arm Description

immunosuppressant treatment regimens the intervention is antirejection treatment with the above labeled drugs tacrolimus and cyclosporine

immunosuppressant treatment regimensthe intervention is antirejection treatment with the above labeled drugs MMF tacrolimus and cyclosporine

immunosuppressant treatment regimens

Outcomes

Primary Outcome Measures

Freedom From Acute Rejection or HCV Recurrence or Treatment Failure
Freedom from acute rejection (Banff>grade 2 with RAI score>4) or freedom from HCV recurrence (Batts/Ludwig>Stage 2, or >Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the "Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"
Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure
Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
November 15, 2016
Sponsor
Baylor Research Institute
Collaborators
Baylor Health Care System, Emory University, University of Southern California, Mayo Clinic - Scottsdale/Phoenix, Arizona, New York Presbyterian Hospital, Oregon Health and Science University, New York University, University of Cincinnati, University of Alabama at Birmingham, The University of Texas Health Science Center at San Antonio, University of Chicago, University of California, San Francisco, Mayo Clinic - Rochester, Minnesota, Medical University of South Carolina, University of Virginia, Lahey Clinic, University of Medicine and Dentistry of New Jersey, Northwestern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00163657
Brief Title
Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection
Official Title
An Open-Label, Randomized, Prospective Multicenter Study To Compare The Efficacy And Safety Among 3 Immunosuppressant Treatment Regimens In Patients Receiving A Liver Transplant For ESLD Caused By Chronic Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
Baylor Health Care System, Emory University, University of Southern California, Mayo Clinic - Scottsdale/Phoenix, Arizona, New York Presbyterian Hospital, Oregon Health and Science University, New York University, University of Cincinnati, University of Alabama at Birmingham, The University of Texas Health Science Center at San Antonio, University of Chicago, University of California, San Francisco, Mayo Clinic - Rochester, Minnesota, Medical University of South Carolina, University of Virginia, Lahey Clinic, University of Medicine and Dentistry of New Jersey, Northwestern Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.
Detailed Description
End-stage liver disease due to Hepatitis C virus (HCV) infection is the most common reason for liver transplantation in the United States. Patients who have HCV will always carry the virus in their body. If patients respond to treatment, the virus is no longer active. This means that although the virus is still present, it is not currently causing damage to their liver. Because recurrence of HCV is virtually universal in HCV positive transplant recipients and is associated with long term, possibly lethal complications, the search for the most appropriate therapies must also include methods to prevent or minimize recurrence or disease progression, if the goal of improving long term outcomes for these patients is to be achieved. Corticosteroids and high doses of immunosuppressive agents have been associated with increased rates of HCV recurrence. Finding a regimen that provides adequate immunosuppression to prevent early and late rejection episodes, and minimizes steroid usage as well as high doses of other immunosuppressive agents is highly desirable. This study is being conducted to determine the most effective immunosuppressive regimen that will prevent allograft rejection, minimize adverse events and at the same time, prevent or reduce the incidence of HCV recurrence following liver transplant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver Disease, Hepatitis C
Keywords
Hepatitis C Virus, Immunosuppressive Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tacrolimus and cyclosporine
Arm Type
Active Comparator
Arm Description
immunosuppressant treatment regimens the intervention is antirejection treatment with the above labeled drugs tacrolimus and cyclosporine
Arm Title
MMF, tacrolimus and cyclosporine
Arm Type
Active Comparator
Arm Description
immunosuppressant treatment regimensthe intervention is antirejection treatment with the above labeled drugs MMF tacrolimus and cyclosporine
Arm Title
daclizumub, MMFand tacrolimus
Arm Type
Active Comparator
Arm Description
immunosuppressant treatment regimens
Intervention Type
Drug
Intervention Name(s)
Daclizumub
Other Intervention Name(s)
Zenapax
Intervention Description
anti-rejection drug
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Prograf
Intervention Description
anti rejection drug
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Other Intervention Name(s)
Neoral
Intervention Description
anti rejection drug
Intervention Type
Drug
Intervention Name(s)
MMF
Other Intervention Name(s)
mycophenolate mofetil
Intervention Description
anti rejection drug
Primary Outcome Measure Information:
Title
Freedom From Acute Rejection or HCV Recurrence or Treatment Failure
Description
Freedom from acute rejection (Banff>grade 2 with RAI score>4) or freedom from HCV recurrence (Batts/Ludwig>Stage 2, or >Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the "Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"
Time Frame
12 months
Title
Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure
Description
Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence
Time Frame
12 month post transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures for the full 2 years. Patient is a recipient of a primary whole/split, cadaveric/living donor liver transplant for end stage chronic Hepatitis C. Patient is > age 18. Female patients of child bearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion. Exclusion Criteria: Patient has previously received or is receiving an organ transplant other than a liver. Patient has received a liver transplant from a Hepatitis B core antibody or a Hepatitis C antibody positive donor. Patient has received an ABO (blood group anti A, anti B antibodies) incompatible donor liver. Patient has fulminant liver failure with a life expectancy without a liver transplant of less than 7 days as defined by UNOS (Adult Patient Status 1, UNOS Policy 3.6.4.1: See Appendix C). Patient has renal dysfunction pre-transplant that, in the opinion of the investigator, will prohibit the use of calcineurin inhibitors within 72 hours post transplant. Patient is intubated, on vasopressors, is ICU bound, or has experienced a significant blood loss (greater than 5 units) 72 hours prior to transplant procedure. Recipient or donor is seropositive for human immunodeficiency virus (HIV) or HbsAg positive serology. Patient is to receive antilymphocyte antibody induction therapy, such as ATGAM (lymphocyte immune globulin), OKT3 (muromonab-CD3), Simulect (basiliximab), or Thymoglobulin. Patient has a known hypersensitivity to Prograf (TAC), HCO-60, CellCept (MMF), Zenapax or corticosteroids. Patient is pregnant or lactating. Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment. Patient has participated in a trial involving a market drug within 30 days. However, patients who participated in any interferon or ribavirin trials are permitted.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Goran Klintmalm, MD
Organizational Affiliation
Baylor Univeristy Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Regional Transplant Institute - Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No their is not a plan to make individual Participant data available

Learn more about this trial

Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection

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