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

Liver Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209675
• Other study ID #: tissue C4d
• Status: Completed
• Phase: N/A
• First received: July 31, 2014
• Last updated: October 12, 2014
• Start date: December 2012
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Other:
• liver biopsy
C4d assessment by immunohistchemistry in liver biopsy

Locations

Country	Name	City	State
Egypt	Ain Shams center for organ transplant (ASCOT)	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years	No