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A Phase II Trial to Assess the Safety of Immunosuppression Withdrawal in Liver Transplant Recipients


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatitis C, Hepatitis C, Chronic, Nonimmune Nonviral Causes of Liver Failure

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Trial Information

A Phase II Trial to Assess the Safety of Immunosuppression Withdrawal in Liver Transplant Recipients


Inclusion Criteria:



- Active hepatitis C virus (HCV) infection with genotype 1 OR nonimmune, nonviral liver
disease

- Needs liver transplant

- Willing to use acceptable forms of contraception

Exclusion Criteria:

- Previous transplant

- Multiorgan or split liver transplant other than a right trisegment

- Living donor transplant

- Donor liver from a donor positive for antibody against hepatitis B core antigen

- Donor liver from a donor positive for antibody against hepatitis C

- Donor liver from a non-heart-beating donor

- Liver failure due to autoimmune disease

- Fulminant liver failure

- Hepatitis B virus infection or HCV infection with a genotype other than genotype 1

- Stage III or higher hepatocellular cancer

- History of cancer. Patients with hepatocellular cancer, adequately treated in situ
cervical carcinoma, adequately treated basal or squamous cell carcinoma of skin, or
other cancer judged to have a 5-year risk of recurrence less than 10% are not
excluded.

- Active systemic infection at the time of transplantation

- Clinically significant chronic kidney disease

- Clinically significant cardiovascular or cerebrovascular disease

- HIV infected

- Pregnancy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of participants with progression of hepatitis C-related liver disease,

Outcome Description:

This is a composite endpoint comprising specific clinical complications related to immunosuppression and is defined as the occurrence anytime in the 24 months after random assignment of any one of the following: death or graft loss, grade 4 secondary malignancy, grade 4 opportunistic infection, grade 3 or higher viral hepatitis, or grade 2 or higher decrease in GFR

Outcome Time Frame:

In the 2 years following random assignment

Safety Issue:

Yes

Principal Investigator

Abraham Shaked, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

DAIT ITN030ST

NCT ID:

NCT00135694

Start Date:

October 2005

Completion Date:

November 2015

Related Keywords:

  • Hepatitis C
  • Hepatitis C, Chronic
  • Nonimmune Nonviral Causes of Liver Failure
  • hepatitis
  • hepatitis C
  • HCV
  • liver
  • liver disease
  • liver transplant
  • liver transplantation
  • transplant
  • hepatic
  • hepatic transplantation
  • immunosuppression
  • rejection
  • Hepatitis
  • Hepatitis A
  • Hepatitis C
  • Liver Failure
  • Hepatitis C, Chronic

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
University of ColoradoDenver, Colorado  80217
University of WashingtonSeattle, Washington  98195
University of California, San FranciscoSan Francisco, California  94143
Baylor UniversityWaco, Texas  
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Northwestern UniversityChicago, Illinois  60611
Cleveland ClinicCleveland, Ohio  44195