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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
Patients with liver cirrhosis confirmed by reliable biopsy (within 12 months) or reliable Fibroscan >15 kPa at screening.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to six weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have confirmed liver cirrhosis either through a biopsy or a Fibroscan result greater than 15 kPa.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities
incidence of AEs
incidence of stopping criteria
Secondary outcome measures
AUC of PHIN-214
AUC of PHIN-214 metabolite
PK of PHIN-214
+1 more
Other outcome measures
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What results is the clinical trial hoping to produce?

"Per PharmaIN, the sponsor of this clinical trial, the primary outcome will be observed over a two week period and concerns dose limiting toxicities. In addition to this metric, there are three secondary outcomes that need to be measured: plasma concentration of PHIN-214 (PK), AUC of PHIN-214 (AUC) and AUC of its metabolite."

Answered by AI

Are individuals over the age of fifty being accepted into this medical research?

"This medical trial calls for applicants aged 18-70. For minors and seniors, there are 76 trials and 444 trials respectively that they may qualify for."

Answered by AI

What is the scope of participants being recruited for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, the investigation that was made available on March 1st of this year is still recruiting individuals. 13 participants are needed to be recruited from 2 sites and the trial's entry has recently been refreshed as of September 8th, 2022."

Answered by AI

Do the criteria of this clinical research allow me to partake?

"As of now, this medical trial is looking for 13 candidates with ascites between 18 and 70 years old. Eligibility requires a body mass index within the range of 18 to 40 kg/m2 at screening; females must be non-pregnant or capable of conceiving but using highly efficient contraception; patients should have liver cirrhosis confirmed by reliable biopsy (within 12 months) or Fibroscan reading beyond 15 kPa at the start."

Answered by AI

Is there still room for volunteers to participate in this experiment?

"Affirmative, clinicaltrials.gov confirms that this research endeavour is presently enrolling individuals. It was initially announced on March 1st 2022 and further amended on August 9th of the same year. 2 sites need to recruit 13 subjects a piece in total."

Answered by AI

What risk factors are associated with PHIN-214 Subcutaneous injection?

"Our team at Power gave PHIN-214 Subcutaneous injection a score of 1, indicating that there is limited evidence to support the safety and efficacy of this drug given it's in Phase 1."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
Arizona
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have been diagnosed with saroses of the liver.
PatientReceived 1 prior treatment
~19 spots leftby Oct 2025