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

An Observational Follow-on Study to Describe the Pharmacogenetics of the CC-90007-CP-003 Study Cohort

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Insufficiency

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014-3616
      • Clinical Pharmacology of Miami, LLC
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center OCRC
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approximately 28 subjects from the CC-90007-CP-003 study (from any race, males or non-pregnant and non-nursing females) will be enrolled. The study will be conducted at approximately 3 sites in the US that participated in the CC-90007-CP-003 study. Subjects may not be replaced with subjects that did not participate in the CC-90007-CP-003 study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria	DNA Quality	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs)	Number of participants with adverse event	Time from ICF to Day 1

Collaborators and Investigators

• Sponsor: Celgene

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Healthy Subject; Hepatic impairment; CC-90007-CP-003
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency
• Other Study ID Numbers: NDS-CP-003; U1111-1237-0411 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No