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Albutein for Cirrhosis (PRECIOSA Trial)
PRECIOSA Trial Summary
This trial will compare the standard treatment for decompensated cirrhosis plus Albutein to standard treatment alone, in order to evaluate the efficacy of Albutein.
PRECIOSA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPRECIOSA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PRECIOSA Trial Design
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Who is running the clinical trial?
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- I have been diagnosed with liver cirrhosis.I currently have an SBP infection.I am 18 years old or older.I have worsening cirrhosis from hepatitis C and won't get antiviral therapy during the study.I have cirrhosis from hepatitis B and have been on antiviral therapy for at least 3 months.I currently have COVID-19, am recovering, or show symptoms of it.I was hospitalized for a severe worsening of liver cirrhosis with fluid buildup.My liver disease worsened while I was on hepatitis B treatment.I can give or have someone authorized to give my consent for participation.I am 18 years old or older.I have kidney disease with kidney failure.My liver disease worsened while I was on continuous immune-suppressing medication.I was hospitalized for severe liver issues with fluid buildup but don't have acute liver failure now.My liver disease worsened while I was on continuous immune-suppressing medication.I was hospitalized for severe liver issues with fluid buildup but don't have acute liver failure now.I have a TIPS or another type of liver shunt.I am experiencing septic shock.I have worsening cirrhosis from hepatitis C and won't get antiviral therapy during the study.My cancer has spread beyond its original location.I am being treated for type 1 HRS with vasoconstrictors or hemodialysis.I am on blood thinner medication.I have heart failure.I have a severe lung condition.I am HIV positive.I have had recent bleeding from enlarged veins.I've had up to 2 treatments for esophageal varices before screening.I have severe fluid buildup in my abdomen not responding to treatment, without other complications.I am not pregnant, breastfeeding, and if able to have children, I agree to use contraception.
- Group 1: Standard Medical Treatment + Albutein 20%
- Group 2: Standard Medical Treatment
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 is the FDA's stance on Standard medical treatment?
"Standard medical treatment received a score of 3."
What is the most usual form of medical care given for this condition?
"Peritonitis is most commonly treated with standard medical interventions. However, this treatment can also be used to address various other conditions such as liver failure and respiratory distress syndrome in adults."
Are there other examples in the medical literature of Standard medical treatment?
"The first clinical trial for standard medical treatment was conducted in 2007 at Herbert Irving Pavillion 11th Floor. Since then, a total of 178 clinical trials have been completed. As of now, there are 139 active trials recruiting patients; many of these are based in Columbia, South carolina."
What is the enrollment for this clinical trial?
"That is correct. The information available on clinicaltrials.gov indicates that this study was originally posted on July 24th, 2018 and is still recruiting participants. Currently, 410 individuals are needed for the trial which is being conducted at 9 different locations."
Has a trial like this been conducted before?
"Standard medical treatment has a long research history, with the first clinical trial taking place in 2007. That initial study was sponsored by Celgene Corporation and involved 47 patients. After receiving Phase 1 & 2 drug approval in 2007, there are now 139 live studies involving Standard medical treatment across 33 countries and 918 cities"
Could you please inform me how many different locations are conducting this trial at the moment?
"There are many medical centres participating in this trial, some of which include University of Missouri Hospital, University of Ottawa, and University Health Network - Toronto General Hospital."
Are there any unfilled positions in this trial for potential participants?
"That is correct. The clinical trial, which was originally posted on July 24th, 2018 and updated on October 28th, 2020, is actively recruiting participants. 9 different locations are looking for a total of 410 individuals to fill the open slots."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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