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

NCT04097704 | Completed

• 2 other identifiers: NDS-CP-003U1111-1237-0411
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatic Insufficiency

Keywords

Hepatic impairment; CC-90007-CP-003; Healthy Subject

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria

  DNA Quality

  Day 1

Secondary Outcomes (1)

• Adverse Events (AEs)

  Time from ICF to Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (3)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014-3616, United States

Location

Orlando Clinical Research Center OCRC

Orlando, Florida, 32809, United States

Location

Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Leon Carayannopoulos, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 20, 2019
• Study Start: September 4, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (3)