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

Hepatic Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097704
• Other study ID #: NDS-CP-003
• Secondary ID: U1111-1237-0411
• Status: Completed
• Start date: September 4, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: May 2020
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure

Locations

Country	Name	City	State
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	Orlando Clinical Research Center OCRC	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria	DNA Quality	Day 1
Secondary	Adverse Events (AEs)	Number of participants with adverse event	Time from ICF to Day 1