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

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ClinicalTrials.gov Identifier: NCT04097704
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Hepatic Insufficiency

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Study Type : Observational
Estimated 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 : September 4, 2019
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : October 15, 2019



Primary Outcome Measures :
  1. Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria [ Time Frame: Day 1 ]
    DNA Quality


Secondary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Time from ICF to Day 1 ]
    Number of participants with adverse event



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097704


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
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United States, Florida
Clinical Pharmacology of Miami, LLC Not yet recruiting
Miami, Florida, United States, 33014-3616
Orlando Clinical Research Center OCRC Not yet recruiting
Orlando, Florida, United States, 32809
United States, Tennessee
Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville Recruiting
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Leon Carayannopoulos, MD Celgene Corporation

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04097704     History of Changes
Other Study ID Numbers: NDS-CP-003
U1111-1237-0411 ( Other Identifier: WHO )
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Hepatic impairment
CC-90007-CP-003
Healthy Subject
Additional relevant MeSH terms:
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Hepatic Insufficiency
Liver Failure
Liver Diseases
Digestive System Diseases