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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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2010 Phase 4 trial • 1034 Patients • NCT00966355Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: multiple daily dosing of PHIN-214
- Group 2: single dose of PHIN-214
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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