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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 from time of dose to the final follow-up visit (day 21 [± 4 days])
Awards & highlights
Study Summary
This trial will see if a liver condition affects how a drug is processed and how safe it is for people to take.
Who is the study for?
Adults aged 18-85 with chronic and stable liver cirrhosis who weigh at least 50kg, have a BMI of 18-40 kg/m2, and can give informed consent. Participants must use contraception if applicable. Excluded are those with fluctuating liver function, severe diseases, recent medication changes, non-liver related hepatic impairment, certain blood count levels, transplants or infections like hepatitis B/C or HIV.Check my eligibility
What is being tested?
The trial is studying how people with different levels of liver disease process the drug Mitiperstat. It will look at how the body absorbs and eliminates it (pharmacokinetics), as well as its safety and tolerability in participants with hepatic impairment.See study design
What are the potential side effects?
While specific side effects for Mitiperstat aren't listed here, common ones for drugs tested in people with liver conditions may include gastrointestinal issues, fatigue, allergic reactions and potential impact on blood counts or organ functions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of dose to the final follow-up visit (day 21 [± 4 days])
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of dose to the final follow-up visit (day 21 [± 4 days])
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apparent Clearance (CL/F)
Apparent terminal elimination half-life (t½λz)
Area under the concentration-time curve from time zero to infinity (AUCinf)
+8 moreSecondary outcome measures
Adverse Events (AEs), and Serious Adverse Events (SAEs)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
8-12 participants with normal hepatic function will be given Dose A of mitiperstat.
Group II: Cohort 3Experimental Treatment1 Intervention
6-8 participants with severe hepatic impairment (Child-Pugh C) will be given Dose A of mitiperstat.
Group III: Cohort 2Experimental Treatment1 Intervention
8 participants with moderate hepatic impairment (Child-Pugh B) will be given Dose A of mitiperstat.
Group IV: Cohort 1Experimental Treatment1 Intervention
8 participants with mild hepatic impairment (Child-Pugh A) will be given Dose A of mitiperstat.
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,643 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function is quickly getting worse.I am between 18 and 85 years old.I need frequent procedures to remove excess fluid from my abdomen.I have documents proving my liver cirrhosis with impairment.My liver issues are not due to damage in the liver tissue itself.I do not have any severe illnesses or lab results that would make it unsafe for me to join the study.I have had pancreatitis or my pancreas enzymes are high.I have had a liver transplant.My medication dose has not changed in the last 2 weeks.My weight is at least 50kg and my BMI is between 18 and 40.I am currently pregnant or breastfeeding.I have had bleeding from enlarged veins in my esophagus in the last 3 months.I have liver issues and previously had a TIPS procedure.I am able to understand and sign the consent form.I am not currently breastfeeding.I am either male or female.I have a liver condition that affects my brain.My liver condition is chronic and stable.I agree to use birth control during and 4 weeks after the study if I can have children and am sexually active.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3
- Group 2: Cohort 1
- Group 3: Cohort 4
- Group 4: Cohort 2
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the qualifications to partake in this clinical trial?
"The criteria for this investigation necessitates that applicants have a liver ailment and are aged between 18 - 85. A total of 32 individuals shall be admitted in the trial."
Answered by AI
Is Cohort 1 compliant with Food and Drug Administration standards?
"Cohort 1's safety score is ranked a 1 due to the limited clinical data that exists as this trial is in its first stage."
Answered by AI
Does the research include elderly participants aged 70 or above?
"This investigation will accept patients aged between 18 and 85; however, there is a separate cohort of 22 trials for minors younger than 18 years old as well as an additional 226 clinical trials specifically designed to cater to the needs of seniors above 65."
Answered by AI
Is participation in this research trial still available for interested individuals?
"It seems that recruitment for this medical trial is no longer active, as the listing on clinicaltrials.gov has not been updated since February 21st 2023. However, there are still 257 other trials actively seeking participants at present."
Answered by AI
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