AscitesPhase 2NCT05867602
High Dose Albumin in Refractory Ascites
A Phase 2 study testing Albumin in people with Ascites, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Advanced cirrhosis with complications is a serious problem imposing a heavy financial burden on health care system. Moreover, ascites is associated with increase in mortality rates among cirrhotic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites
- What is being tested?
- Albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 25 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- patients diagnosed with liver cirrhosis.
- Refractory ascites which is defined as ascites failing to resolve after maximum tolerable dose of diuretics, and usually require frequent paracentesis.
Who cannot join
- Patients < 18y
- patients with no history of liver cirrhosis
- patients with refractory ascites but have transjagular intrahepatic portosystemic shunts (TIPS) with previous 3 months
- Patients with ascites due to other causes, including cardiac, malignant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor St' Lukes Medical center
Houston, Texas, 77030
Prasun K Jalal, MD, 8323551424, jalal@bcm.edu
Prasun K Jalal, MD
About this study
Official title: Clinical Efficacy of High-dose Albumin Administration Versus Standard Dose in Patients With Advanced Cirrhosis: Open Label Randomized Clinical Trial
Advanced cirrhosis with complications is a serious problem imposing a heavy financial burden on health care system. Moreover, ascites is associated with increase in mortality rates among cirrhotic patients. Ascites pathogenesis is multifactorial including: portal hypertension; splanchnic and peripheral arterial vasodilation; and neurohumoral activation. Current management strategies include dietary sodium restriction and diuretic therapy, however, this strategy put patients at the risk of intravascular volume depletion, renal impairment, hepatic encephalopathy and hyponatremia. Moreover, around 10% of patients do not respond to this strategy (termed: diuretics resistant) with 50% of them die within 6 months. This sub-group is managed by frequent large volume paracentesis along with intravenous albumin administration and are usually considered for liver transplantation (LT) and TIPS. Nonetheless, Frequent paracentesis increases the risk of infection, bleeding, bowel perforation, paracentesis-induced circulatory dysfunction (PICD) and renal dysfunction in this sub-group of patients. The beneficial effect of human albumin might result from blood volume expansion tapering activated vasoconstrictor and sodium-retaining systems improving renal perfusion, hence regular infusion of albumin may be beneficial to prevent development of ascites and to improve survival. The positive effects of albumin are supported by previous studies; Romanelli et al, showed a significant increase in survival rate among cirrhotic patients with ascites when compared to those who did not receive albumin. Moreover, a randomized multicenter open label trial published in lancet last year, demonstrated that long term albumin administration improved 18-month survival, decreased the use of paracentesis and decrease in the incidence of cirrhosis related complications among cirrhotic patients with ascites. As of today, there's a limited use of regular high dose albumin in cirrhotic patients with ascites in US, despite being used elsewhere in the world as previously stated.
The investigators wish to study long-term efficacy of human albumin administration in patients with decompensated cirrhosis to assess safety and efficacy, and prevention of complications of cirrhosis.
Read the detailed description
Patients with advanced liver disease often has low serum albumin level. The Infusion of human albumin is a standard of care after removal of ascitic fluid in patients with cirrhosis with refractory ascites. The objective of the study is to prove that regular infusion of albumin prevents formation of fluid in abdomen (ascites) or pleural fluid (Hydrothorax) and thus reduces the requirement of paracentesis or thoracentesis, and prevent complications.
The Primary endpoints are: (1) Number of paracentesis/thoracentesis needed and volume of fluid removed per month and if there is any reduction in frequency or volume after high-dose albumin administration; (2) Twelve-month mortality or transplant. Secondary endpoints are: (1) Improvement of MELD score; (2) Cumulative diuretic dosage; (3) Development of hyponatremia or hyperkalemia as potential diuretic-induced side-effects; (4) Incidence of cirrhosis related complications (spontaneous bacterial peritonitis, other bacterial infections, renal impairment, hepatorenal syndrome, hepatic encephalopathy and gastrointestinal bleeding related to portal hypertension); (5) Quality of life; (6) Number and duration of hospital admissions; and (7) Treatment cost-effectiveness.
The research design is a prospective, parallel, randomized, open label clinical trial. The target trial population comprises of patients with advanced cirrhosis. Eligible patients will be randomized into either one of two categories: 1) the control group will receive the standard of care (SOC) including moderate sodium restriction and maximal daily tolerated doses of diuretics, and 2) the Intervention group will receive intravenous human albumin at a dose (1g/kg, with minimum dose of 50g and maximum dose of 100g) weekly plus SOC.
In both groups, when large-volume paracentesis is needed, the patient will receive human albumin in the dose of 6-8 g/L of ascites removed as SOC.
Inclusion Criteria:
- Age > 18 years.
- patients diagnosed with liver cirrhosis. Refractory ascites which is defined as ascites failing to resolve after maximum tolerable dose of diuretics, and usually require frequent paracentesis.
Exclusion Criteria:
- Patients < 18y and patients with no history of liver cirrhosis
- patients with refractory ascites but have trans-jagular intrahepatic portosystemic shunts (TIPS) with previous 3 months
- Patients with ascites due to other causes, including cardiac, malignant Procedure Eligible patients will be identified by the PI and the research team. Participants will be approached to participate in the study. The research coordinator will fully explain the study procedures, and if the patient is willing to participate, he or she will sign the informed consent. After signing the informed consent, eligible patients will be randomly assigned into two groups: 1) the control arm will receive the standard of care (SOC), including moderate sodium restriction, maximal daily tolerated doses of diuretics, and post-paracentesis albumin, and 2) 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. patients will be randomly assigned (1:1) to either of these two groups.
In both groups, when large-volume paracentesis is needed, the participant will receive human albumin in the dose of 6-8 g/L of ascites removed.
No concomitant medications are withheld during the study. After enrollment, participants will be assessed by a physician monthly for up to one year or study interruption or liver transplant or death. In both groups with refractory ascites, most of the patient require weekly or biweekly monitoring and paracentesis. The investigators plan to approach the patients during these visits to get the consent and administer the extra albumin dose.
In each visit, ascites severity will be evaluated with hemodynamic status, weight, new symptoms, and diuretic dose. Each visit may last 15 minutes or more.
Patients who consent to the study will complete a self-administered questionnaire to assess health-related quality of life (using CLDQ, CLDQ-HCV and CLDQ- NASH Questionnaires). Each patient response will be coded to ensure privacy, and the coded data will be entered into a collection sheet with no protected health information (PHI) gathered during the survey. The investigators will give the questionnaire: at the time of enrollment and at the 6 and 12 month time points
- Conditions
- Ascites
- Being tested
- Albumin
- Keywords
- refractory ascites, liver cirrhosis, HRS, High dose albumin
- Medical subject headings
- Ascites, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminDrug
Also called High dose albumin (HA)
intravenous human albumin at a dose of (1g/kg), with a minimum dose of 50g and a maximum dose of 100g
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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 Receives: Drug: Albumin |
| Control arm | No 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of large volume paracentesis needed
Number of paracentesis/thoracentesis needed.
Measured: 1 year
The volume of fluid removed in liters per after high-dose albumin administration
Measuring the fluid amount removed each paracentesis and compare it to before High dose albumin administration
Measured: 1 year
Secondary outcomes (6)
Incidence of cirrhosis related complications (spontaneous bacterial peritonitis, other bacterial infections, renal impairment, hepatorenal syndrome, hepatic encephalopathy and gastrointestinal bleeding related to portal hypertension).
Each attack of decompensation will be documented during enrollment. We will compare number of decompensation episodes in each group
Measured: 1 year
Diuretics dosage assessment
Trend for Dosage of diuretics required in mg during the enrollment period.
Measured: 1 Year
Liver related quality of life assessment.
Liver related quality of life assessment.
Measured: 1 year
Mortality at 1 year after enrollment
Twelve-month mortality
Measured: 1 year
Number and duration of hospital admissions
Number of visits to ER, hospital admissions will also be assessed
Measured: 1 year
Treatment cost-effectiveness.
Cost of albumin vs cost of paracentesis and paracentesis related hospitalizations
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start25 Mar 2019
- Primary completion25 Mar 2027 (estimated)
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prasun Kumar Jalal, Baylor College of Medicine
- Investigators
- Prasun Jalal, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867602
- Sponsor's protocol ID
- H-49043
- Status last verified
- Sep 2025
- First submitted
- 20 Apr 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Pascoli M, Ceranto E, De Nardi P, Donato D, Gatta A, Angeli P, Pontisso P. Hospitalizations Due to Cirrhosis: Clinical Aspects in a Large Cohort of Italian Patients and Cost Analysis Report. Dig Dis. 2017;35(5):433-438. doi: 10.1159/000458722. Epub 2017 Mar 1.
PubMed 28245467Gines P, Quintero E, Arroyo V, Teres J, Bruguera M, Rimola A, Caballeria J, Rodes J, Rozman C. Compensated cirrhosis: natural history and prognostic factors. Hepatology. 1987 Jan-Feb;7(1):122-8. doi: 10.1002/hep.1840070124.
PubMed 3804191Schmidt ML, Barritt AS, Orman ES, Hayashi PH. Decreasing mortality among patients hospitalized with cirrhosis in the United States from 2002 through 2010. Gastroenterology. 2015 May;148(5):967-977.e2. doi: 10.1053/j.gastro.2015.01.032. Epub 2015 Jan 23.
PubMed 25623044Pedersen JS, Bendtsen F, Moller S. Management of cirrhotic ascites. Ther Adv Chronic Dis. 2015 May;6(3):124-37. doi: 10.1177/2040622315580069.
PubMed 25954497Moore KP, Aithal GP. Guidelines on the management of ascites in cirrhosis. Gut. 2006 Oct;55 Suppl 6(Suppl 6):vi1-12. doi: 10.1136/gut.2006.099580. No abstract available.
PubMed 16966752Pache I, Bilodeau M. Severe haemorrhage following abdominal paracentesis for ascites in patients with liver disease. Aliment Pharmacol Ther. 2005 Mar 1;21(5):525-9. doi: 10.1111/j.1365-2036.2005.02387.x.
PubMed 15740535Romanelli RG, La Villa G, Barletta G, Vizzutti F, Lanini F, Arena U, Boddi V, Tarquini R, Pantaleo P, Gentilini P, Laffi G. Long-term albumin infusion improves survival in patients with cirrhosis and ascites: an unblinded randomized trial. World J Gastroenterol. 2006 Mar 7;12(9):1403-7. doi: 10.3748/wjg.v12.i9.1403.
PubMed 16552809
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of High-dose Albumin Administration Versus Standard Dose in Patients With Advanced Cirrhosis: Open Label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05867602
- Acronym / sponsor ID
- H-49043
- Conditions
- Ascites
- Keywords
- refractory ascites, liver cirrhosis, HRS, High dose albumin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 25 Mar 2027 (estimated)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Advanced cirrhosis with complications is a serious problem imposing a heavy financial burden on health care system. Moreover, ascites is associated with increase in mortality rates among cirrhotic patients. Ascites pathogenesis is multifactorial including: portal hypertension; splanchnic and peripheral arterial vasodilation; and neurohumoral activation. Current management strategies include dietary sodium restriction and diuretic therapy, however, this strategy put patients at the risk of intravascular volume depletion, renal impairment, hepatic encephalopathy and hyponatremia. Moreover, around 10% of patients do not respond to this strategy (termed: diuretics resistant) with 50% of them die within 6 months. This sub-group is managed by frequent large volume paracentesis along with intravenous albumin administration and are usually considered for liver transplantation (LT) and TIPS. Nonetheless, Frequent paracentesis increases the risk of infection, bleeding, bowel perforation, paracentesis-induced circulatory dysfunction (PICD) and renal dysfunction in this sub-group of patients. The beneficial effect of human albumin might result from blood volume expansion tapering activated vasoconstrictor and sodium-retaining systems improving renal perfusion, hence regular infusion of albumin may be beneficial to prevent development of ascites and to improve survival. The positive effects of albumin are supported by previous studies; Romanelli et al, showed a significant increase in survival rate among cirrhotic patients with ascites when compared to those who did not receive albumin. Moreover, a randomized multicenter open label trial published in lancet last year, demonstrated that long term albumin administration improved 18-month survival, decreased the use of paracentesis and decrease in the incidence of cirrhosis related complications among cirrhotic patients with ascites. As of today, there's a limited use of regular high dose albumin in cirrhotic patients with ascites in US, despite being used elsewhere in the world as previously stated.
The investigators wish to study long-term efficacy of human albumin administration in patients with decompensated cirrhosis to assess safety and efficacy, and prevention of complications of cirrhosis.
Detailed description
Patients with advanced liver disease often has low serum albumin level. The Infusion of human albumin is a standard of care after removal of ascitic fluid in patients with cirrhosis with refractory ascites. The objective of the study is to prove that regular infusion of albumin prevents formation of fluid in abdomen (ascites) or pleural fluid (Hydrothorax) and thus reduces the requirement of paracentesis or thoracentesis, and prevent complications.
The Primary endpoints are: (1) Number of paracentesis/thoracentesis needed and volume of fluid removed per month and if there is any reduction in frequency or volume after high-dose albumin administration; (2) Twelve-month mortality or transplant. Secondary endpoints are: (1) Improvement of MELD score; (2) Cumulative diuretic dosage; (3) Development of hyponatremia or hyperkalemia as potential diuretic-induced side-effects; (4) Incidence of cirrhosis related complications (spontaneous bacterial peritonitis, other bacterial infections, renal impairment, hepatorenal syndrome, hepatic encephalopathy and gastrointestinal bleeding related to portal hypertension); (5) Quality of life; (6) Number and duration of hospital admissions; and (7) Treatment cost-effectiveness.
The research design is a prospective, parallel, randomized, open label clinical trial. The target trial population comprises of patients with advanced cirrhosis. Eligible patients will be randomized into either one of two categories: 1) the control group will receive the standard of care (SOC) including moderate sodium restriction and maximal daily tolerated doses of diuretics, and 2) the Intervention group will receive intravenous human albumin at a dose (1g/kg, with minimum dose of 50g and maximum dose of 100g) weekly plus SOC.
In both groups, when large-volume paracentesis is needed, the patient will receive human albumin in the dose of 6-8 g/L of ascites removed as SOC.
Inclusion Criteria:
- Age > 18 years.
- patients diagnosed with liver cirrhosis. Refractory ascites which is defined as ascites failing to resolve after maximum tolerable dose of diuretics, and usually require frequent paracentesis.
Exclusion Criteria:
- Patients < 18y and patients with no history of liver cirrhosis
- patients with refractory ascites but have trans-jagular intrahepatic portosystemic shunts (TIPS) with previous 3 months
- Patients with ascites due to other causes, including cardiac, malignant Procedure Eligible patients will be identified by the PI and the research team. Participants will be approached to participate in the study. The research coordinator will fully explain the study procedures, and if the patient is willing to participate, he or she will sign the informed consent. After signing the informed consent, eligible patients will be randomly assigned into two groups: 1) the control arm will receive the standard of care (SOC), including moderate sodium restriction, maximal daily tolerated doses of diuretics, and post-paracentesis albumin, and 2) 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. patients will be randomly assigned (1:1) to either of these two groups.
In both groups, when large-volume paracentesis is needed, the participant will receive human albumin in the dose of 6-8 g/L of ascites removed.
No concomitant medications are withheld during the study. After enrollment, participants will be assessed by a physician monthly for up to one year or study interruption or liver transplant or death. In both groups with refractory ascites, most of the patient require weekly or biweekly monitoring and paracentesis. The investigators plan to approach the patients during these visits to get the consent and administer the extra albumin dose.
In each visit, ascites severity will be evaluated with hemodynamic status, weight, new symptoms, and diuretic dose. Each visit may last 15 minutes or more.
Patients who consent to the study will complete a self-administered questionnaire to assess health-related quality of life (using CLDQ, CLDQ-HCV and CLDQ- NASH Questionnaires). Each patient response will be coded to ensure privacy, and the coded data will be entered into a collection sheet with no protected health information (PHI) gathered during the survey. The investigators will give the questionnaire: at the time of enrollment and at the 6 and 12 month time points
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Drug: Albuminthe 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 |
| Control arm | No 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years.
- patients diagnosed with liver cirrhosis.
- Refractory ascites which is defined as ascites failing to resolve after maximum tolerable dose of diuretics, and usually require frequent paracentesis.
Key exclusion criteria (4 listed)
- Patients < 18y
- patients with no history of liver cirrhosis
- patients with refractory ascites but have transjagular intrahepatic portosystemic shunts (TIPS) with previous 3 months
- Patients with ascites due to other causes, including cardiac, malignant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbuminAlso: High dose albumin (HA)intravenous human albumin at a dose of (1g/kg), with a minimum dose of 50g and a maximum dose of 100g | Drug | Intervention arm |
Primary outcome
Number of large volume paracentesis needed
Time frame: 1 year
Number of paracentesis/thoracentesis needed.
The volume of fluid removed in liters per after high-dose albumin administration
Time frame: 1 year
Measuring the fluid amount removed each paracentesis and compare it to before High dose albumin administration
6 secondary outcomes
Incidence of cirrhosis related complications (spontaneous bacterial peritonitis, other bacterial infections, renal impairment, hepatorenal syndrome, hepatic encephalopathy and gastrointestinal bleeding related to portal hypertension).
Time frame: 1 year
Diuretics dosage assessment
Time frame: 1 Year
Liver related quality of life assessment.
Time frame: 1 year
Mortality at 1 year after enrollment
Time frame: 1 year
Number and duration of hospital admissions
Time frame: 1 year
Treatment cost-effectiveness.
Time frame: 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Results publication: PubMed 28245467Di Pascoli M, Ceranto E, De Nardi P, Donato D, Gatta A, Angeli P, Pontisso P. Hospitalizations Due to Cirrhosis: Clinical Aspects in a Large Cohort of Italian Patients and Cost Analysis Report. Dig Dis. 2017;35(5):433-438. doi: 10.1159/000458722. Epub 2017 Mar 1.
- Results publication: PubMed 3804191Gines P, Quintero E, Arroyo V, Teres J, Bruguera M, Rimola A, Caballeria J, Rodes J, Rozman C. Compensated cirrhosis: natural history and prognostic factors. Hepatology. 1987 Jan-Feb;7(1):122-8. doi: 10.1002/hep.1840070124.
- Results publication: PubMed 25623044Schmidt ML, Barritt AS, Orman ES, Hayashi PH. Decreasing mortality among patients hospitalized with cirrhosis in the United States from 2002 through 2010. Gastroenterology. 2015 May;148(5):967-977.e2. doi: 10.1053/j.gastro.2015.01.032. Epub 2015 Jan 23.
- Results publication: PubMed 25954497Pedersen JS, Bendtsen F, Moller S. Management of cirrhotic ascites. Ther Adv Chronic Dis. 2015 May;6(3):124-37. doi: 10.1177/2040622315580069.
- Results publication: PubMed 16966752Moore KP, Aithal GP. Guidelines on the management of ascites in cirrhosis. Gut. 2006 Oct;55 Suppl 6(Suppl 6):vi1-12. doi: 10.1136/gut.2006.099580. No abstract available.
- Results publication: PubMed 15740535Pache I, Bilodeau M. Severe haemorrhage following abdominal paracentesis for ascites in patients with liver disease. Aliment Pharmacol Ther. 2005 Mar 1;21(5):525-9. doi: 10.1111/j.1365-2036.2005.02387.x.
- Results publication: PubMed 16552809Romanelli RG, La Villa G, Barletta G, Vizzutti F, Lanini F, Arena U, Boddi V, Tarquini R, Pantaleo P, Gentilini P, Laffi G. Long-term albumin infusion improves survival in patients with cirrhosis and ascites: an unblinded randomized trial. World J Gastroenterol. 2006 Mar 7;12(9):1403-7. doi: 10.3748/wjg.v12.i9.1403.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prasun Jalal, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albumin in people with Ascites, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prasun Jalal, MD (8323551424, jalal@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of large volume paracentesis needed (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05867602, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.