Role of Tissue C4d in Differentiation Between Acut e Rejection and HCV Recurrence After Liver Transplantation

October 12, 2014 updated by: Iman Fawzy Montasser, Ain Shams University
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

Study Overview

Status

Completed

Conditions

Intervention / 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

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams center for organ transplant (ASCOT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: patients with elevated liver enzymes
Patients with elevated liver enzymes and/or hyperbilirubinemia post transplantation for hepatitis C virus related disease will have liver biopsy
Other: liver biopsy
C4d assessment by immunohistchemistry in liver biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who developed Acute cellular rejection after transplantation
Time Frame: 2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

August 5, 2014

First Posted (ESTIMATE)

August 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 12, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tissue C4d

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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