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

Celgene

Status: Completed

Conditions: Hepatic Insufficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT04097704

U1111-1237-0411 (Other Identifier)

NDS-CP-003

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Each subject must satisfy all of the following criteria to be enrolled in this study:

1. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
2. 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.
3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
4. Subject participated in the CC-90007-CP-003 study.

Exclusion criteria

The presence of any of the following will exclude a subject from enrollment:

1. Subject has any condition which places the subject at unacceptable risk if he/she were to participate in the study.
2. 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.