Trial Information

Summary: (Elite ReSpECT Study) - A Study of Zenapax (Daclizumab) in Patients Who Have Undergone Liver Transplantation

Status: Completed

Protocol Number: ML17521

Sponsor: F Hoffman-La Roche Ltd; Queen Elizabeth Hospital Birmingham NHS Trust

Company Division: Pharmaceutical

Official Scientific Title: An exploratory study to evaluate the efficacy, safety, particularly renal function, and tolerability of three regimes of immunosuppressive therapy, in patients who have undergone liver transplantation.

Brief Summary: This study will evaluate renal function, efficacy and safety in liver transplant patients receiving immunosuppressive therapy including Cellcept, or CellCept + Zenapax, against a comparator regimen. The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals. Target sample size is 525.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Liver Transplantation

Intervention Type: Drug

Intervention Name: daclizumab[Zenapax]

Primary Outcome: 1. Renal function, as measured by change from baseline in calculated creatinine clearance

Key Secondary Outcomes: 1. Change from baseline for serum creatinine at 13, 26, 52 wks and for calculated creatinine clearance at 13, 26 wks posttransplantation Safety: AEs, hypertension, diabetes, hyperlipidaemia, and OIs

Inclusion Criteria:

  • male or female patients >=16 years of age;
  • single-organ liver transplant (whole or split);
  • women of child-bearing potential must be prepared to use reliable contraception throughout the study, and for up to 4 months after the last dose of study medication.

Exclusion Criteria:

  • previous organ transplant;
  • pregnant women;
  • HIV positive patients;
  • prohibited immunosuppressive agents prior to transplant (or known to be required after transplant);
  • patients who have received another investigational drug within 30 days preceding transplantation.

Gender: Males or Females

Age Limits: Min: 16 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Oslo, Norway, 0027
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: August 20, 2008 at 2:16:01 PM


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