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

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT04097704

Collaborator

(none)

Enrollment

Locations

1.9

Actual Duration (Months)

9.3

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Insufficiency

Study Design

Study Type:

Observational

Actual Enrollment :

28 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 4, 2019

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Nov 1, 2019

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

Celgene

Investigators

Study Director: Leon Carayannopoulos, MD, Celgene Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Celgene

ClinicalTrials.gov Identifier:

NCT04097704

Other Study ID Numbers:

NDS-CP-003
U1111-1237-0411

First Posted:

Sep 20, 2019

Last Update Posted:

May 21, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Celgene

Hepatic impairment

CC-90007-CP-003

Healthy Subject

Additional relevant MeSH terms:

Hepatic Insufficiency

Liver Failure

Study Results

No Results Posted as of May 21, 2020