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Tyrosine Kinase Inhibitor
Pacritinib for Liver Disease
Phase 1
Recruiting
Research Sponsored by CTI BioPharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14 arauc0-12
Awards & highlights
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.
Who is the study for?
This trial is for adults aged 18-85 with chronic liver disease, who are either surgically sterile, postmenopausal, or willing to use birth control. Men must also agree to contraception rules. Participants should be in stable health aside from their liver condition and have a Body Mass Index (BMI) between 18.0 and 42.0.Check my eligibility
What is being tested?
The study tests the safety and how the body processes pacritinib when taken orally at a dose of 200 mg twice daily by people with moderate to severe liver impairment compared to healthy individuals over a period of two weeks.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally such trials look out for any adverse reactions ranging from mild symptoms like nausea or headaches to more serious issues affecting organ function or causing allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 14 arauc0-12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14 arauc0-12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PK
Secondary outcome measures
Electrocardiogram
Incidence of adverse events
Incidence of clinical laboratory abnormalities
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Severe Hepatic ImpairmentExperimental Treatment1 Intervention
Subjects with severe hepatic impairment based on Child-Pugh Class C score of 10-15 will receive 14 days of 200 mg BID pacritinib.
Group II: Normal Hepatic FunctionExperimental Treatment1 Intervention
Healthy subjects who have normal hepatic function with age (± 10 years; ≥ 18 years old and ≤ 85 years old), BMI (±20%), and sex, matching with the moderate and severe hepatic impairment cohorts will receive 14 days of 200 mg BID pacritinib.
Group III: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Subjects with moderate hepatic impairment based on Child-Pugh Class B score of 7-9 will receive 14 days of 200 mg BID pacritinib.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
CTI BioPharmaLead Sponsor
63 Previous Clinical Trials
5,341 Total Patients Enrolled
PPDIndustry Sponsor
161 Previous Clinical Trials
36,957 Total Patients Enrolled
Sarah Buckley, MDStudy DirectorCTI BioPharma
1 Previous Clinical Trials
60 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Normal Hepatic Function
- Group 2: Severe Hepatic Impairment
- Group 3: Moderate Hepatic Impairment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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