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

Completed

• Conditions: Hepatic Insufficiency

• Registration Number: NCT04097704
• Lead Sponsor: Celgene

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-04
• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-20
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-20
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria	Day 1	DNA Quality

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	Time from ICF to Day 1	Number of participants with adverse event

Trial Locations

Locations (3)

Orlando Clinical Research Center OCRC; 🇺🇸 Orlando, Florida, United States

Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville; 🇺🇸 Knoxville, Tennessee, United States

Clinical Pharmacology of Miami, LLC; 🇺🇸 Miami, Florida, United States