Phase 4
N=312
Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection
End Stage Liver Disease · Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT00163657 ↗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
| Outcome | Result | p-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.
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.