Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort

Completed

Conditions studied: Hepatic Insufficiency

In brief

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 subjects with moderate and severe hepatic impairment and healthy control subjects with normal hepatic function will be enrolled.

Key facts

Study ID

NCT04097704

Run by

Celgene

People needed

28

Starts

2019-09-04

Expected to finish

2019-11-01

Last updated by the study team

2020-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Pharmacology of Miami, LLC — Miami, Florida, United States
• Orlando Clinical Research Center OCRC — Orlando, Florida, United States
• Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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