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Immunosuppressant

1 for Liver Dysfunction

Phase 2
Waitlist Available
Research Sponsored by Genzyme, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection. This study will evaluate the effect of Thymoglobulin induction therapy and reduced doses of calcineurin inhibitors on the incidence of liver rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help decrease the incidence of liver transplant rejection. Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. Approximately 75 study subjects from up to 18 transplant centers in the United States and Canada will be enrolled in this 12-month study.

Eligible Conditions
  • Liver Dysfunction
  • Transplant Rejection
  • Liver Transplant

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment3 Interventions
Standard (tacrolimus based standard therapy without induction)
Group II: 2 Standard of CareActive Control3 Interventions
Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antithymocyte immunoglobulin (rabbit)
FDA approved
Tacrolimus
FDA approved
Mycophenolate mofetil
FDA approved

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyLead Sponsor
526 Previous Clinical Trials
185,545 Total Patients Enrolled
Medical MonitorStudy DirectorGenzyme, a Sanofi Company
1,673 Previous Clinical Trials
988,360 Total Patients Enrolled
~4 spots leftby Sep 2025