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

NCT ID: NCT00295607

Last Updated: 2013-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C Liver Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

immunosuppression

steroids, monoclonal anti-IL2R antibody

Intervention Type DRUG

immunosuppression

2

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

immunosuppression

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tacrolimus

immunosuppression

Intervention Type DRUG

steroids, monoclonal anti-IL2R antibody

immunosuppression

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Prograf, FK506

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Physician

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Prague, , Czechia

Site Status

Besançon, , France

Site Status

Lyon, , France

Site Status

Nice, , France

Site Status

Villejuif, , France

Site Status

Berlin, , Germany

Site Status

Hamburg, , Germany

Site Status

Mainz, , Germany

Site Status

Bologna, , Italy

Site Status

Genova, , Italy

Site Status

Modena, , Italy

Site Status

Warsaw, , Poland

Site Status

Barakaldo, , Spain

Site Status

Madrid, , Spain

Site Status

Santiago, , Spain

Site Status

Gothenburg, , Sweden

Site Status

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Czechia France Germany Italy Poland Spain Sweden United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FG-506-01-28

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Faecal Microbiota Transplantation for Liver Cirrhosis
NCT04932577 RECRUITING PHASE2/PHASE3