CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 312 enrolled
Drug / intervention
Daclizumub +3 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Recipient of a primary whole or split liver transplant from cadaveric or living donor for end-stage chronic hepatitis C
  • ✓Age greater than 18 years
  • ✓Fully informed and signed IRB-approved informed consent; willing and able to follow study procedures for 2 years
Key exclusion· 8
  • ✕Previous receipt of any organ transplant other than liver
  • ✕Liver transplant from HBV core antibody positive, HCV antibody positive, or ABO-incompatible donor
  • ✕Fulminant liver failure with life expectancy <7 days without transplant (UNOS Status 1)
  • ✕Pre-transplant renal dysfunction that would prohibit calcineurin inhibitor use within 72 hours post-transplant

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00163657
NCT00163657Phase 4Completed
CompareCT.gov

An Open-Label, Randomized, Prospective Multicenter Study To Compare The Efficacy And Safety Among 3 Immunosuppressant Treatment Regimens In Patients Receiving A Liver Transplant For ESLD Caused By Chronic Hepatitis C

Baylor Research Institute·interventional·Posted Sep 14, 2005·Updated Jan 12, 2017

In Brief

A Phase 4 clinical trial evaluating Daclizumub, Tacrolimus, and 2 other interventions for End Stage Liver Disease and Hepatitis C. Completed, enrolled 312 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Liver Disease, Hepatitis C
CountriesUnited States
CollaboratorsBaylor Health Care System, Emory University, University of Southern California, Mayo Clinic - Scottsdale/Phoenix, Arizona, New York Presbyterian Hospital, Oregon Health and Science University, New York University, University of Cincinnati, University of Alabama at Birmingham, The University of Texas Health Science Center at San Antonio, University of Chicago, University of California, San Francisco, Mayo Clinic - Rochester, Minnesota, Medical University of South Carolina, University of Virginia, Lahey Clinic, University of Medicine and Dentistry of New Jersey, Northwestern Memorial Hospital

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartJul 1, 2002
Primary CompletionApr 1, 2006
Study CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.8 years ago

Interventions

Daclizumubdrug

anti-rejection drug

Tacrolimusdrug

anti rejection drug

Cyclosporinedrug

anti rejection drug

MMFdrug

anti rejection drug