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Completed

NCT Number: NCT00295607

Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients

This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prague, Czechia

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About this study

A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic administration and anti-rejection treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis are eligible for the study.
  • Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included.

Exclusion criteria

  • Recipient of multi-organ transplant
  • Recipient of an auxiliary graft
  • Patient is receiving ABO incompatible graft
  • Patients requiring immunosuppressive treatment
  • Patients requiring ongoing corticosteroid therapy.
  • Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
  • Patient or donor is known to be HIV positive.
  • Patient is allergic or intolerant to study medication
  • Patient is pregnant or breast-feeding.
  • Patient has been previously enrolled in this study

Treatment and study plan

Tacrolimus

Drug

immunosuppression

Other names: Prograf, FK506

steroids, monoclonal anti-IL2R antibody

Drug

immunosuppression

Primary outcomes

  1. Viral load of HCV at 12 months post transplantation

    Time frame: 12 months

Secondary outcomes

  1. Biopsy-proven acute rejection

    Time frame: 12 months

  2. Acute rejection

    Time frame: 12 months

  3. Patient and graft survival

    Time frame: 12 months

  4. Incidence of adverse events

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation

Acronym: CHASE

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 24, 2006
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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