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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
You have been diagnosed with Liver Cirrhosis
You have been diagnosed with Liver Cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to six weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new compound to see if it is safe and tolerated in patients with cirrhosis. The goal is to find the maximum dose that is safe for patients.
Who is the study for?
This trial is for adults with a BMI of 18-40 who have liver cirrhosis confirmed by biopsy or Fibroscan. They must not be pregnant, breastfeeding, and should use effective contraception. Excluded are those with significant heart, lung, kidney diseases, certain hepatitis conditions, hepatic encephalopathy grade 1 or higher, TIPS recipients, HIV positive individuals or those with fluid/sodium balance disorders.
What is being tested?
The study tests PHIN-214 via subcutaneous injection to assess its safety and how the body processes it in patients with mild to moderate liver cirrhosis (Child-Pugh A and B). It aims to find the highest dose patients can tolerate without serious side effects through escalating doses.
What are the potential side effects?
Potential side effects of PHIN-214 may include reactions at the injection site such as pain or swelling. Since it's being tested on people with liver issues, there might also be risks related to worsening of liver function which will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to sixweeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to sixweeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of dose limiting toxicities
incidence of AEs
incidence of stopping criteria
Secondary study objectives
AUC of PHIN-214
AUC of PHIN-214 metabolite
PK of PHIN-214
+1 moreOther study objectives
various exploratory markers of efficacy
Side effects data
From 2010 Phase 4 trial • 1034 Patients • NCT009663551%
diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Octreotide
Somatostatin
Terlipressin
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: single dose of PHIN-214Experimental Treatment1 Intervention
single ascending dose of PHIN-214
Group II: multiple daily dosing of PHIN-214Experimental Treatment1 Intervention
multiple doses of PHIN-214, daily for 28 days
Find a Location
Who is running the clinical trial?
PharmaINLead Sponsor
Cynthia C Jones, BSStudy ChairPharmaIN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive, confirmed by a viral load test.I have chronic hepatitis B but haven't changed my treatment in the last 4 weeks.I do not have major heart, lung, or blood pressure problems.My kidney function is reduced, with an eGFR below 60 or creatinine above 2.0 mg/dL.I have a serious kidney condition.I have mild confusion due to liver problems.I have received a TIPS procedure for liver issues.I am not pregnant, breastfeeding, and either cannot have children or am using effective birth control.I have confirmed liver cirrhosis either through a biopsy or a Fibroscan result greater than 15 kPa.Your body mass index (BMI) falls between 18 to 40 kg/m2 at the time of screening.I have a history of conditions affecting my body's fluid or sodium balance.
Research Study Groups:
This trial has the following groups:- Group 1: multiple daily dosing of PHIN-214
- Group 2: single dose of PHIN-214
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.
Liver Cirrhosis Patient Testimony for trial: Trial Name: NCT05490888 — Phase 1
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