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Apalutamide for Liver Disease
Study Summary
This trial will look at how well the body processes a new drug, apalutamide, in people with severely impaired liver function compared to those with normal liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 86 Patients • NCT03279250Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- My liver is severely impaired, with a Child-Pugh score between 10 to 15.My kidney function is normal, with creatinine levels within the normal range.My liver functions normally and I am in good health.I have normal liver function and may have been exposed to Hepatitis A, B, or C.I have normal liver function but experience sexual dysfunction.My kidney function is good, with a filtration rate of at least 45 mL/min.My liver functions normally and I am in good health.My liver is severely impaired and getting worse quickly.I have severe liver problems and was diagnosed with liver cancer.I have severe liver problems with a specific score.My kidney function is good, with a filtration rate of at least 45 mL/min.I do not have severe confusion due to liver problems.My kidney function is normal, with creatinine levels within the normal range.I do not have severe liver-related brain issues that prevent me from understanding this study.
- Group 1: Group 1: Participants with Severe Hepatic Impairment
- Group 2: Group 2: Participants with Normal Hepatic Function
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this trial pioneering for its respective field?
"Research into the efficaciousness of apalutamide began in 2014, and was sponsored by Aragon Pharmaceuticals. Following a successful Phase 3 trial involving 982 participants, it received its drug approval. Nowadays, 44 studies utilizing apalutamide are being conducted around the world across 552 cities spread over 38 countries."
Can I apply to be a participant in this trial?
"Patients who are afflicted with hepatic impairment and between the ages of 18 and 80 may be eligible to join this trial. In total, 16 individuals will receive admittance into the study."
Can you provide a list of research trials which have tested Apalutamide's efficacy?
"Apalutamide was first tested in a clinical trial with the identifier NCT02257736 back in 2014. Since then, 18 further trials have been successfully completed and 44 are actively recruiting patients primarily from Orlando, Florida."
What potential risks are associated with Apalutamide use?
"Our researchers at Power have assigned Apalutamide a score of 1 due to its Phase 1 trial status, which implies that the available data regarding safety and efficacy is limited."
Are geriatric patients within the parameters of eligibility for this clinical trial?
"This clinical research has specific enrolment requirements, which states that prospective participants must be between 18 to 80 years old. There are 27 studies specifically for minors and 267 individual cases involving seniors."
To what extent has the patient recruitment process been successful for this medical experiment?
"Affirmative. The relevant clinicaltrials.gov page suggests that this medical experiment is still searching for participants and was first uploaded on November 7th, 2019 with the last update being made on 22nd of November 2022. This trial seeks to enlist 16 individuals from two different sites."
Is enrollment open for this trial?
"As per the clinicaltrials.gov page, recruitment for this trial is ongoing and was initially announced on November 7th 2019 with last update taking place on November 22nd 2022."
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