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NCT Number: NCT04097704

Pharmacogenetics Sampling 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.

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Key information

Conditions

Hepatic Insufficiency Digestive System Diseases Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Pharmacology of Miami, LLC, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Day 1

    DNA Quality

Secondary outcomes

  1. Adverse Events (AEs)

    Time frame: Time from ICF to Day 1

    Number of participants with adverse event

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2019
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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