Status:
COMPLETED
Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort
Lead Sponsor:
Celgene
Conditions:
Hepatic Insufficiency
Eligibility:
All Genders
18+ years
Brief Summary
This is a multi-center observational follow-up study to collect saliva samples that allow pharmacogenetic analysis of the subjects that participated in the CC-90007-CP-003 study. Approximately 28 sub...
Eligibility Criteria
Inclusion
- Each subject must satisfy all of the following criteria to be enrolled in this study:
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules and other protocol requirements.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject participated in the CC-90007-CP-003 study.
Exclusion
- The presence of any of the following will exclude a subject from enrollment:
- Subject has any condition which places the subject at unacceptable risk if he/she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Sponsor's medical monitor should be consulted on suspected conditions under this exclusion criterion, prior to exclusion.
Key Trial Info
Start Date :
September 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04097704
Start Date
September 4 2019
End Date
November 1 2019
Last Update
May 21 2020
Active Locations (3)
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1
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33014-3616
2
Orlando Clinical Research Center OCRC
Orlando, Florida, United States, 32809
3
Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, United States, 37920