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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1237-0411 | Other Identifier | WHO |
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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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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria | DNA Quality | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Number of participants with adverse event | Time from ICF to Day 1 |
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Inclusion Criteria:
Each subject must satisfy all of the following criteria to be enrolled in this study:
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
Sponsor's medical monitor should be consulted on suspected conditions under this exclusion criterion, prior to exclusion.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Leon Carayannopoulos, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, LLC | Miami | Florida | 33014-3616 | United States | ||
| Orlando Clinical Research Center OCRC |
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/
See Plan Description
See Plan Description
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Orlando |
| Florida |
| 32809 |
| United States |
| Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville | Knoxville | Tennessee | 37920 | United States |