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Pacritinib for Liver Disease
Study Summary
This trial will study if people with liver problems can safely take a new medicine, pacritinib, and how the medicine works in these people.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- I am between 18 and 85 years old.I have taken over-the-counter drugs or supplements in the last 2 weeks.I have a condition that affects how my body handles medications.I do not have a history or symptoms of severe brain dysfunction due to liver disease.My heart's electrical cycle is longer than normal.My liver condition is not worsening.I am a male willing to use birth control or abstain from sex during the study and for 90 days after.I had a serious heart problem in the last 6 months.I have been treated with pacritinib before.I have not taken strong CYP3A4 affecting drugs in the last 30 days.I have had a significant bleeding event in the last 3 months.I have taken blood thinners in the last 14 days.I have heart failure that affects my daily activities.I haven't started new medications in the last 15 days due to liver issues.I haven't taken prescription meds in the last 30 days.Despite my liver issues, I am in good overall health.My liver function is stable and not worsening quickly.I will not donate sperm from the start of the trial until 90 days after Day 21.I am either not able to have children, past menopause, or I use birth control.I do not have a positive test for drugs or alcohol.I do not have active hepatitis B.I do not have severe health issues that would stop me from joining the study.I am a woman who cannot become pregnant or will use birth control during the study.I do not need fluid removed from my abdomen more than once every 3 weeks.I am a male willing to use birth control or abstain from sex if my partner can have children.I smoke more than 10 cigarettes a day and can't cut down to 5 or less.I have not donated more than 450 mL of blood in the last 30 days.I have been seriously ill in the last 2 weeks.I have long-term (over 6 months) and stable liver impairment.My resting heart rate is either below 50 or above 100, and my body temperature is either below 35.0°C or above 37.5°C.I am a woman who can have children and have had negative pregnancy tests.I do not have hepatorenal syndrome.I have never had a surgery to create a shortcut in my liver's blood flow.My liver isn't working well, and my blood tests show severe problems.
- Group 1: Normal Hepatic Function
- Group 2: Severe Hepatic Impairment
- Group 3: Moderate Hepatic Impairment
- 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
Are there any unfilled slots available in this clinical trial?
"Clinicaltrials.gov confirms that this medical trial is still recruiting, having been posted on December 12th 2022 and refreshed lastly on May 8th 2023."
How many participants are currently participating in the research?
"Affirmative. According to clinicaltrials.gov, the information pertaining to this trial was first posted on December 12th 2022 and recently updated on May 8th 2023. The study is searching for 32 individuals who will be based out of a single site."
Does the trial have any age restrictions for participants?
"This medical trial is open to patients aged 18-85. There are 24 studies available for minors and 240 experiments that cater to seniors over 65 years old."
Who is eligible to enroll in this medical study?
"This clinical trial is currently recruiting 32 participants with liver disease, aged between 18 and 85. Eligibility requirements for enrolment include the ability to give written informed consent; having a BMI of 18-42 kg/m2; being surgically sterile, postmenopausal or willing to use an acceptable form of birth control (for female subjects); refraining from sperm donation (for male subjects); having chronic hepatic impairment as assessed by Child-Pugh classification score 7-15 points; being judged in good general health based on medical history, laboratory assessments and physical examination findings; and finally - normal hepatic function."
To what degree are individuals affected by Moderate Hepatic Impairment?
"Our internal assessment provided Moderate Hepatic Impairment with a score of 1 due to the lack of safety and efficacy data available in its Phase 1 clinical trial."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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