Hepatic InsufficiencyNCT04097704
Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort
An observational study of Hepatic Insufficiency, run by Celgene at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Sep 2019to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, 37920
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014-3616
Orlando Clinical Research Center OCRC
Orlando, Florida, 32809
About this study
Official title: An Observational Follow-on Study to Describe the Pharmacogenetics 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.
- Conditions
- Hepatic Insufficiency
- Keywords
- Hepatic impairment, CC-90007-CP-003, Healthy Subject
- Medical subject headings
- Hepatic Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria
DNA Quality
Measured: Day 1
Secondary outcomes (1)
Adverse Events (AEs)
Number of participants with adverse event
Measured: Time from ICF to Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start4 Sep 2019
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leon Carayannopoulos, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097704
- Sponsor's protocol ID
- NDS-CP-003
- Other IDs
- U1111-1237-0411
- Status last verified
- May 2020
- First submitted
- 19 Sep 2019
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Follow-on Study to Describe the Pharmacogenetics of the CC-90007-CP-003 Study Cohort
- ClinicalTrials.gov ID
- NCT04097704
- Acronym / sponsor ID
- NDS-CP-003
- Conditions
- Hepatic Insufficiency
- Keywords
- Hepatic impairment, CC-90007-CP-003, Healthy Subject
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria
Time frame: Day 1
DNA Quality
1 secondary outcome
Adverse Events (AEs)
Time frame: Time from ICF to Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leon Carayannopoulos, MD study director
Celgene Corporation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Insufficiency, run by Celgene at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.