Moderate Hepatic Impairment for Liver Disease

Orlando Clinical Research, Orlando, FL
Liver Diseaseoral dose of 200 mg pacritinib twice daily (BID) - Drug
Eligibility
18 - 85
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Liver Disease

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Day 14 ARAUC0-12

Day 1-21
Incidence of clinical laboratory abnormalities
Physical Examination
Incidence of vital sign abnormalities
Day 1-44
Incidence of adverse events
Safety/Tolerability
Day 14 ARAUC0-12
PK
Day1-21
Electrocardiogram

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Moderate Hepatic Impairment
1 of 3
Severe Hepatic Impairment
1 of 3
Normal Hepatic Function
1 of 3

Experimental Treatment

32 Total Participants · 3 Treatment Groups

Primary Treatment: Moderate Hepatic Impairment · No Placebo Group · Phase 1

Moderate Hepatic Impairment
Drug
Experimental Group · 1 Intervention: oral dose of 200 mg pacritinib twice daily (BID) · Intervention Types: Drug
Severe Hepatic Impairment
Drug
Experimental Group · 1 Intervention: oral dose of 200 mg pacritinib twice daily (BID) · Intervention Types: Drug
Normal Hepatic Function
Drug
Experimental Group · 1 Intervention: oral dose of 200 mg pacritinib twice daily (BID) · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 14 arauc0-12

Who is running the clinical trial?

CTI BioPharmaLead Sponsor
63 Previous Clinical Trials
5,477 Total Patients Enrolled
PPDIndustry Sponsor
151 Previous Clinical Trials
32,367 Total Patients Enrolled
Sarah Buckley, MDStudy DirectorCTI BioPharma
1 Previous Clinical Trials
54 Total Patients Enrolled

Eligibility Criteria

Age 18 - 85 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to read and sign a document that explains the study and gives your permission to participate.
You are able to understand and follow the instructions given by the researcher.
You are between the ages of 18 and 85 during the screening process.
Your body mass index (BMI) falls between 18.0 and 42.0 kg/m2.

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.