Prediction of Hepatitis C Recurrence in Liver Transplant Recipients

NCT00867243 | Terminated

• 1 other identifier: STU12442 1963-002
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Transplanted Liver; Hepatitis C, Chronic

Keywords

Hepatitis C virus; HCV; Hepatitis C (and cirrhosis); Liver cirrhosis not due to HCV infection

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• 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.

  Baseline prior to surgery, Weeks 1, 2; Months 1, 2, 3, 4, 5, 6, 12, 18

Study Arms (2)

Group 1: HCV Positive

50 patients whom are HCV positive

Group 2: HCV Negative

50 patients whom are HCV negative.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Northwestern Memorial Hospital: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 15620458 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Recipient specimens: Peripheral blood draws at baseline and follow-up clinic visits. Donor specimens: Donor cells will be isolated from lymph nodes obtained at time of harvest; if living donor - blood taken at time of liver resection surgery.

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Fibrosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Talia Baker, MD

  Northwestern Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Anat Tambur, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor of Surgery, Division of Organ Transplantation, Dept of Surgery

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 23, 2009
• Study Start: October 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2011
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

US (1)