NCT02209675

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

1.5 years

First QC Date

July 31, 2014

Last Update Submit

October 12, 2014

Conditions

Liver Disease

Keywords

hepatitis C recurrenceRejectionLiver TransplantationLiver biopsy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

patients with elevated liver enzymes

OTHER

Patients with elevated liver enzymes and/or hyperbilirubinemia post transplantation for hepatitis C virus related disease will have liver biopsy

Other: liver biopsy

Interventions

liver biopsyOTHER

C4d assessment by immunohistchemistry in liver biopsy

patients with elevated liver enzymes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Evidence of other causes of elevated liver enzyme and/or hyperbilirubinemia as abnormal Abdominal Doppler ultrasound and/or Magnetic resonance cholangiography MRCP findings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams center for organ transplant (ASCOT)

Cairo, Egypt

Location

MeSH Terms

Conditions

Liver DiseasesRejection, Psychology

Condition Hierarchy (Ancestors)

Digestive System DiseasesSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of tropical medicine , Ain Shams university

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 6, 2014

Study Start

December 1, 2012

Primary Completion

June 1, 2014

Study Completion

October 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

EG(1)