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Plasma Expander
High Dose Albumin for Ascites
Phase 2
Recruiting
Led By Prasun Jalal, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1year
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how regular albumin infusion might improve survival and reduce complications in cirrhotic patients with ascites.
Who is the study for?
This trial is for adults over 18 with liver cirrhosis and refractory ascites, which means their body retains fluid despite maximum diuretic treatment and often needs excess fluid removed.
What is being tested?
The study tests the long-term effects of high-dose human albumin in patients with advanced liver disease to see if it can prevent complications and improve survival by expanding blood volume.
What are the potential side effects?
Potential side effects may include allergic reactions, infection risks due to frequent infusions, bleeding issues, or worsening heart function due to increased blood volume.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of large volume paracentesis needed
The volume of fluid removed in liters per after high-dose albumin administration
Secondary study objectives
Diuretics dosage assessment
Incidence of cirrhosis related complications (spontaneous bacterial peritonitis, other bacterial infections, renal impairment, hepatorenal syndrome, hepatic encephalopathy and gastrointestinal bleeding related to portal hypertension).
Liver related quality of life assessment.
+3 moreSide effects data
From 2012 Phase 4 trial • 29 Patients • NCT001083558%
GI Bleeding
8%
Hepatic encephalopathy
8%
Scrotal edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Albumin (Control Group)
Vasoconstrictor (Treatment Group)
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
Active Control
Group I: Intervention armExperimental Treatment1 Intervention
the intervention group will receive intravenous human albumin at a dose of (1g/kg), with a minimum dose of 50g and a maximum dose of 100g, plus SOC
Group II: Control armActive Control1 Intervention
the control arm will receive the standard of care (SOC), including moderate sodium restriction, maximal daily tolerated doses of diuretics, and post-paracentesis albumin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Albumin
2015
Completed Phase 4
~7990
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,062 Total Patients Enrolled
1 Trials studying Ascites
Prasun Jalal, MDPrincipal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ascites hasn't improved despite maximum diuretic treatment and needs frequent draining.I have never had liver cirrhosis.I have fluid in my abdomen not caused by heart or cancer issues.I am older than 18 years.I have been diagnosed with liver cirrhosis.I am under 18 years old.I have ascites not responding to treatment and got a TIPS procedure within the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention arm
- Group 2: Control arm
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.