Status:
WITHDRAWN
A Study to Compare the Effectiveness of a Drug That Suppresses the Immune System Called Thymoglobulin® in Preventing the Development of a Disease That Affects the Majority of Heart Transplant Recipients Called Cardiac Allograft Vasculopathy (CAV)
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Cardiac Allograft Vasculopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test the hypothesis that administering Thymoglobulin® induction therapy early after transplant prevents the development of cardiac allograft vasculopathy (CAV). CAV acc...
Eligibility Criteria
Inclusion
- Subjects must be undergoing their first allograft transplant
- Men and non-pregnant women must be 18 to 70 years old
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to transplantation. The sensitivity must be equal to at least 50 mIU/mL. (Urine test is allowed in addition to serum test in patients where serum results are delayed).
- Women of childbearing potential must use two reliable forms of contraception simultaneously. Effective contraception must be used before beginning study drug therapy, and for 4 months following discontinuation of study drug therapy.
- Subjects must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
Exclusion
- Previous organ transplants
- Patients receiving multiple organs
- Patients \> 250 lbs or 114 kgs
- Patients requiring VAD upon completion of transplantation surgery. \[Patients who require LVADs prior to surgery may be enrolled as long as no presurgery immunosuppressives (see list in Appendix B) were administered.\]
- Women lactating, pregnant, or of childbearing potential, not using, or who are unwilling to use two reliable forms of contraception simultaneously during the study.
- Men who are not using a reliable contraceptive method
- History of a psychological illness or condition which would interfere with the patient's ability to understand the requirements of the study
- White blood cell count ≤ 2500/mm3, or platelets ≤ 50,000/mm3, or hemoglobin ≤ 6g/dL
- HIV-1, HTLV-1, chronic Hepatitis B, or chronic Hepatitis C infection
- Documented or strong suspicion for pre-operative active infection that has not yet been adequately treated with the recommended course of antimicrobial therapy
- Presence of any chronic myelosuppressive disease or agent that has resulted in either chronic leucopenia or chronic thrombocytopenia
- Active peptic ulcer disease
- Patients who have received within the past 30 days or require concomitant treatment with other investigational drugs (except for those listed in section 8.6 "Concomitant treatment") or immunosuppressive medications that are prohibited for this study (Appendix B)
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01157949
Start Date
November 1 2010
End Date
January 10 2018
Last Update
March 14 2019
Active Locations (1)
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1
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211