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Phase 4 N=312 Randomized Treatment

Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection

End Stage Liver Disease · Hepatitis C

Enrolled (actual)
312
Serious AEs
12.8%
Results posted
Jan 2017
Primary outcome: Primary: Freedom From Acute Rejection or HCV Recurrence or Treatment Failure — 69; 70; 133 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Daclizumub (Drug); Tacrolimus (Drug); Cyclosporine (Drug); MMF (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Baylor Research Institute
Primary completion
Apr 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Freedom From Acute Rejection or HCV Recurrence or Treatment Failure
69; 70; 133
PRIMARY
Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure
39; 39; 72

Summary

The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.

Eligibility Criteria

Inclusion Criteria

  • Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures for the full 2 years.
  • Patient is a recipient of a primary whole/split, cadaveric/living donor liver transplant for end stage chronic Hepatitis C.
  • Patient is > age 18.
  • Female patients of child bearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion.

Exclusion Criteria

  • Patient has previously received or is receiving an organ transplant other than a liver.
  • Patient has received a liver transplant from a Hepatitis B core antibody or a Hepatitis C antibody positive donor.
  • Patient has received an ABO (blood group anti A, anti B antibodies) incompatible donor liver.
  • Patient has fulminant liver failure with a life expectancy without a liver transplant of less than 7 days as defined by UNOS (Adult Patient Status 1, UNOS Policy 3.6.4.1: See Appendix C).
  • Patient has renal dysfunction pre-transplant that, in the opinion of the investigator, will prohibit the use of calcineurin inhibitors within 72 hours post transplant.
  • Patient is intubated, on vasopressors, is ICU bound, or has experienced a significant blood loss (greater than 5 units) 72 hours prior to transplant procedure.
  • Recipient or donor is seropositive for human immunodeficiency virus (HIV) or HbsAg positive serology.
  • Patient is to receive antilymphocyte antibody induction therapy, such as ATGAM (lymphocyte immune globulin), OKT3 (muromonab-CD3), Simulect (basiliximab), or Thymoglobulin.
  • Patient has a known hypersensitivity to Prograf (TAC), HCO-60, CellCept (MMF), Zenapax or corticosteroids.
  • Patient is pregnant or lactating.
  • Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment.
  • Patient has participated in a trial involving a market drug within 30 days. However, patients who participated in any interferon or ribavirin trials are permitted.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00163657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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