Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Graft Vs Host Disease; Kidney Transplantation
Intervention: Sirolimus (RAPAMUNE) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, MD, Study Director, Affiliation: Wyeth
Summary
To evaluate the safety of long-term administration of sirolimus oral solution for up to 5
additional years, or until the tablet formulation is commercially available (whichever occurs
first) in solid organ transplant recipients who are currently receiving sirolimus and who
have completed clinical trials with sirolimus (with or without cyclosporine (CsA). To
evaluate the pharmacokinetics and safety of long-term administration of sirolimus tablets
administered for up to 5 years, or until the tablet formulation is commercially available in
solid organ transplant recipients who are currently receiving sirolimus and who have
completed clinical trials with sirolimus (with or without CsA) or who are currently enrolled
in protocol 0468E1-306-US.
Clinical Details
Official title: An Open-Label Extension Study of the Safety of Long-Term Administration of Sirolimus (Rapamune™) in Solid Organ Transplant Recipients
Study design: Safety Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Completion of sirolimus/blinded therapy in solid organ clinical trials (with or
without CsA) with satisfactory compliance and an adequate safety profile.
- Women of childbearing potential who have a negative pregnancy test before enrollment
into this study and who agree to practice either a hormonal or barrier method of birth
control throughout the treatment period and for 3 months following discontinuation of
sirolimus may be enrolled into the study.
- Signed and dated informed consent
Exclusion Criteria:
- Unstable disease states, which in the opinion of the investigator would present a risk
to the patient.
- Known hypersensitivity to macrolide antibiotics
Locations and Contacts
Edmonton, Alberta T6G 2B7, Canada
Vancouver, British Columbia V5Z 1M9, Canada
Los Angeles, California 90057, United States
San Diego, California 92123, United States
Stanford, California 94304, United States
Los Angeles, California 90095-1752, United States
Tampa, Florida 33606, United States
Atlanta, Georgia 30322, United States
Augusta, Georgia 30912, United States
Chicago, Illinois 60637, United States
Indianapolis, Indiana 46202-5250, United States
New York, New York 10029, United States
Charlotte, North Carolina 28232, United States
Halifax, Nova Scotia B3H 2Y9, Canada
Toronto, Ontario M5G 2C4, Canada
Toronto, Ontario M5B 1W8, Canada
Philadelphia, Pennsylvania 19141, United States
Pittsburgh, Pennsylvania 15213, United States
Montreal, Quebec H2L 2W5, Canada
Charleston, South Carolina 29425-0777, United States
Additional Information
Last updated: May 18, 2006
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