Back to resultsRole of Tissue C4d in Differentiation Between Acut e Rejection and HCV Recurrence After Liver Transplantation
Primary Purpose
Liver Disease
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
liver biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Disease focused on measuring hepatitis C recurrence, Rejection, Liver Transplantation, Liver biopsy
Eligibility Criteria
Inclusion Criteria:
- Patients transplanted for HCV related disease that are presented with elevated liver enzyme and/or hyperbilirubinemia and normal Abdominal Doppler ultrasound and Magnetic resonance cholangiography (MRCP).
Exclusion Criteria:
- Evidence of other causes of elevated liver enzyme and/or hyperbilirubinemia as abnormal Abdominal Doppler ultrasound and/or Magnetic resonance cholangiography MRCP findings.
Sites / Locations
- Ain Shams center for organ transplant (ASCOT)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patients with elevated liver enzymes
Arm Description
Patients with elevated liver enzymes and/or hyperbilirubinemia post transplantation for hepatitis C virus related disease will have liver biopsy
Outcomes
Primary Outcome Measures
Number of participants who developed Acute cellular rejection after transplantation
Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for differentiating between acute rejection and hepatitis C recurrence in recipients post living donor liver transplantation (LDLT) .Each condition require different therapeutic management and the differentiation between them by ordinary methods is confusing due to overlapping pathological features between the rejection and recurrent hepatitis C desease
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02209675
Brief Title
Role of Tissue C4d in Differentiation Between Acut e Rejection and HCV Recurrence After Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for differentiating between acute rejection and Hepatitis C (HCV) recurrence in recipients post living donor liver transplantation (LDLT) .As each condition require different treatment
Detailed Description
Role of tissue c4d assessment by immunohistchemistry in liver biopsy in differentiation between recurrent hepatitis c and rejection after liver transplantation.pathological examination may be sometimes confusing between the rejection and recurrent hepatitis C
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
hepatitis C recurrence, Rejection, Liver Transplantation, Liver biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with elevated liver enzymes
Arm Type
Other
Arm Description
Patients with elevated liver enzymes and/or hyperbilirubinemia post transplantation for hepatitis C virus related disease will have liver biopsy
Intervention Type
Other
Intervention Name(s)
liver biopsy
Intervention Description
C4d assessment by immunohistchemistry in liver biopsy
Primary Outcome Measure Information:
Title
Number of participants who developed Acute cellular rejection after transplantation
Description
Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for differentiating between acute rejection and hepatitis C recurrence in recipients post living donor liver transplantation (LDLT) .Each condition require different therapeutic management and the differentiation between them by ordinary methods is confusing due to overlapping pathological features between the rejection and recurrent hepatitis C desease
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients transplanted for HCV related disease that are presented with elevated liver enzyme and/or hyperbilirubinemia and normal Abdominal Doppler ultrasound and Magnetic resonance cholangiography (MRCP).
Exclusion Criteria:
Evidence of other causes of elevated liver enzyme and/or hyperbilirubinemia as abnormal Abdominal Doppler ultrasound and/or Magnetic resonance cholangiography MRCP findings.
Facility Information:
Facility Name
Ain Shams center for organ transplant (ASCOT)
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Role of Tissue C4d in Differentiation Between Acut e Rejection and HCV Recurrence After Liver Transplantation
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