Prediction of Hepatitis C Recurrence in Liver Transplant... | NCT00867243

Studies
Prediction of Hepatitis C Recurrence in Liver Transplant Recipients

NCT00867243

Sponsor

Northwestern University

Status

Terminated

Last Update Posted

Jun 11, 2013Estimated

Enrollment

24Actual

Phase

Not provided

Conditions

Complication of Transplanted Liver
Hepatitis C, Chronic

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This project is no longer being adequately supported to allow completion

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

May 2010Actual

Completion Date

May 2011Actual

First Submitted Date

Mar 19, 2009

First Submission Date that Met QC Criteria

Mar 20, 2009

First Posted Date

Mar 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2013

Last Update Posted Date

Jun 11, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

TBaker, Assitant Professor of Surgery, Division of Organ Transplantation, Dept of Surgery, Northwestern UniversityPrincipal Investigator

Lead Sponsor

Northwestern UniversityOTHER

Collaborators

Name	Class
Northwestern Memorial Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to look at cells of the immune system to see if the cells are different among people with different risk factors that have received a liver transplant. We will enroll 50 patients receiving liver transplant and their donors. Both donor and recipient must participate in the order for the recipient to participate in the study. We will take blood samples from these patients and their donors.

Detailed Description

To establish whether in-vitro donor-specific immune reactivity patterns can differentiate between those liver transplant recipients who are positive for the Hepatitis C virus (HCV) who are at high risk and those who are at low risk for graft loss secondary to early recurrence of HCV.

An assessment of the recipient's donor-specific immune status can be achieved by measuring T-cell activity, specifically alloreactive primed (donor-specific) T cell activity. It has been shown that detection of IFN-y in short-term enzyme-linked-immunosorbent-spot (ELISPOT) assay is consistent with the presence of primed memory T cells (6). In the transplantation setting, T cells of an allograft recipient that secret IFN-y after short in-vitro exposure to donor cells represent a prior sensitization of recipient to donor antigens in vivo. Clinically interpreted - this priming event may signify the presence of an up-coming, or an on-going, rejection episode. Our limited preliminary data suggest an additional potential clinical value for the in-vitro assessment of donor-specific IFN-y production in predicting those liver transplant recipients at higher risk for recurrence of Hepatitis C.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: HCV Positive		50 patients whom are HCV positive
Group 2: HCV Negative		50 patients whom are HCV negative.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess whether in-vitro donor-specific immune reactivity patterns are indicative of rate of HCV recurrence		Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18

Secondary Outcomes

Measure	Description	Time Frame
To compare in-vitro donor-specific immune reactivity patterns and rejection episodes in liver transplant recipients		Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18
To establish immune monitoring protocol for HCV+ liver transplant recipients that will aid in tailoring immunosuppression protocols for these patients and in devising strategies to treat patients with recurrent hepatitis C post-liver transplantation.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must be >18 years of age
Chronic HCV infection (and cirrhosis) - group 1
HCV RNA positive pre-transplant - group 1
Liver cirrhosis not due to HCV infection - group 2

Exclusion Criteria:

All patients < than 18 years of age
Patients with hepatitis C infection
Candidates receiving multi-organ combined transplantation
Patients who have received a previous liver transplantation
Patients who are unable to understand English

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The target population is males/females over the age of 18 that require liver transplantation, and their donors

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Talia Baker, MD	Northwestern Memorial Hospital	Principal Investigator
Anat Tambur, MD, PhD	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern Memorial Hospital		Chicago	Illinois	60611	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15620458	Background	Tambur AR, Ben-Ari Z, Herrera ND, Klein T, Michowiz R, Mor E. Donor-specific hyporesponsiveness in ELISPOT assay is associated with early recurrence of hepatitis C in liver transplant recipients. Hum Immunol. 2005 Jan;66(1):21-7. doi: 10.1016/j.humimm.2004.08.180.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

ID	Term
D019698	Hepatitis C, Chronic
D006526	Hepatitis C
D005355	Fibrosis