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Study Summary
Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment
- Liver Disease
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 1 & 2 trial • 21 Patients • NCT02273739Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
What goals is this medical experiment aiming to achieve?
"The Celgene-sponsored trial has a main objective of assessing the pharmacokinetics (AUC0-t) of CC-90007 over an extended period. Supplementary objectives include quantifying AUC0–t, AUC 0–∞, and Tmax for AGI-16903."
Has a similar study been conducted before this one?
"Presently, 24 live experiments for Enasidenib are taking place in 28 countries and 84 cities. Celgene initiated the first study of their drug back in 2013 with a total of 345 participants who completed Phase 1 & 2 trials successfully. Since then, 6 additional research projects have been launched."
Are there any identified dangers associated with administering Enasidenib?
"The safety of Enasidenib is rated at 1 given the limited information available from Phase I studies, which indicate potential efficacy but lack comprehensive data on its security."
To whom is this research opportunity available?
"The requirements for inclusion in this trial are hepatic impairment and a patient aged between 40 and 75 years-old. Currently, up to 48 patients will be accepted into the study."
Is the age cutoff for this research endeavor 40 or older?
"This scientific trial is open to those who are between the ages of 40 and 75."
Could you elucidate what other investigations have been undertaken with Enasidenib?
"As of 2013, enasidenib has been the subject of 6 completed trials. At present, there are 24 studies in progress, with a considerable number taking place in Miami, Florida."
To what extent are participants being included in this clinical investigation?
"Affirmative, the clinicaltrials.gov record indicates that this research endeavor is currently enrolling members. It was initially published on November 13th 2020 and its information has been recently revised on November 7th 2022. The project requires a total of 48 individuals to be recruited from 3 separate locations."
Are any new participants being taken on for this clinical experiment?
"As indicated on clinicaltrials.gov, the team behind this medical study is actively seeking volunteers. The trial was originally announced on November 13th 2020 and its most recent update occurred seven months later in July 2022."
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