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Unknown

PHIN-214 for Liver Cirrhosis

Verified Trial
Phase 1
Recruiting
Research Sponsored by PharmaIN
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

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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to sixweeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to sixweeks for reporting.

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 more
Other study objectives
various exploratory markers of efficacy

Side effects data

From 2010 Phase 4 trial • 1034 Patients • NCT00966355
1%
diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Octreotide
Somatostatin
Terlipressin

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

PHIN-214 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05490888 — Phase 1
Liver Cirrhosis Research Study Groups: multiple daily dosing of PHIN-214, single dose of PHIN-214
Liver Cirrhosis Clinical Trial 2023: PHIN-214 Highlights & Side Effects. Trial Name: NCT05490888 — Phase 1
PHIN-214 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05490888 — Phase 1
Liver Cirrhosis Patient Testimony for trial: Trial Name: NCT05490888 — Phase 1
~14 spots leftby Oct 2025
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