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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 weeks
Treatment ~ Varies
Follow Up ~1year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1year for reporting.

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 more

Side effects data

From 2012 Phase 4 trial • 29 Patients • NCT00108355
8%
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
1,024 Previous Clinical Trials
6,029,410 Total Patients Enrolled
1 Trials studying Ascites
Prasun Jalal, MDPrincipal InvestigatorBaylor College of Medicine

Media Library

Albumin (Plasma Expander) Clinical Trial Eligibility Overview. Trial Name: NCT05867602 — Phase 2
Ascites Research Study Groups: Intervention arm, Control arm
Ascites Clinical Trial 2023: Albumin Highlights & Side Effects. Trial Name: NCT05867602 — Phase 2
Albumin (Plasma Expander) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05867602 — Phase 2
~6 spots leftby Mar 2025
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