Acute Variceal BleedingPhase 3ALB-AVBNCT07395141
Albumin in Acute Variceal Bleeding
A Phase 3 study testing Albumin in people with Acute Variceal Bleeding and Cirrhosis, run by King George's Medical University at 1 site in India.
Trial summary
The objective of this randomized control clinical trial is to learn the role of albumin in patients with acute variceal bleed. The trial will include all adult patients with acute variceal bleeding and cirrhosis presenting to Medical Gastroenterology department at KGMU, Lucknow, U.P. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Variceal Bleeding, Cirrhosis
- What is being tested?
- Albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2026to 31 May 2026
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients with acute variceal bleeding and cirrhosis presenting to Medical Gastroenterology department at KGMU, Lucknow, U.P. India.
Who cannot join
- Age < 18 years and > 70 years
- Patients with portal vein thrombosis
- Hepatocellular carcinoma
- Non-cirrhotic portal fibrosis
- Extrahepatic portal vein thrombosis
- Patients who received albumin in the last one month
Show all 10Show fewer
- Patients who require fresh frozen plasma
- Patients with heart failure
- Patients with chronic kidney disease
- Volume overload state
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Dr Sumit Rungta
Lucknow, Uttar Pradesh, 206003
Dr Sumit Rungta, DM-Medical Gastroenterology, +919935537944, drsumitrungta79@gmail.com
Dr Sayan Malakar, DM-Medical Gastroenterology, +919007057890, oneandonlydrsayan@gmail.com
About this study
Official title: Albumin in Acute Variceal Bleeding: A Randomized Controlled Trial: ALB-AVB Trial
The objective of this randomized control clinical trial is to learn the role of albumin in patients with acute variceal bleed. The trial will include all adult patients with acute variceal bleeding and cirrhosis presenting to Medical Gastroenterology department at KGMU, Lucknow, U.P. India, will include patients with age between 18-70 years and all gender.
The primary endpoint will be re-bleeding during hospitalization and at 6 weeks. Participants will be randomized in two groups, the intervention group will receive albumin for 3 days along with standard treatment and comparison group will receive on standard treatment.
Read the detailed description
Albumin in acute variceal bleeding: A randomized controlled trial: ALB-AVB Trial
Introduction:
Albumin has been found to reduce mortality in patients with acute variceal bleeding in retrospective trials. However, there is no prospective data on this issue. We aim to conduct a randomized controlled trial on the role of albumin in patients with acute variceal bleeding.
Review of the literature Acute variceal bleeding is an important decompensating event in patients with cirrhosis. It is associated with 20-30% mortality in six weeks. Standard therapy with splanchnic vasoconstrictors and endoscopic band ligation is the mainstay of treatment. Previous studies have shown that albumin may decrease the mortality and re-bleeding rate in patients with AVB, however, there is no prospective data on this.
Apart from its oncotic properties albumin has different pleiotropic effects in patients with cirrhosis. It is an anti-oxidant and also binds to cytokines. Its anti-inflammatory property is responsible for reducing portal pressure and the risk of rebleeding. Currently, albumin is used in patients with acute kidney injury, spontaneous bacterial peritonitis and during large-volume paracentesis. There is also a theoretical risk of an increase in portal pressure in patients receiving albumin. The role of albumin in AVB is largely unknown. The current recommendation does not support its use in AVB however there is no strong evidence against it too. Currently, albumin has been shown to decrease mortality and decompensation in patients with cirrhosis. Large retrospective data from China have shown that albumin infusion is associated with reduced risk of rebleeding and mortality. In that study IV albumin of 40 grams/ day was associated with reduced mortality in patients with CTP-C cirrhosis. A perfectly designed RCT is warranted to explore the role of albumin in ABV.
Aim of the study:
To explore the role of albumin in patients with AVB. Study Methodology: It will be a randomised controlled trial conducted in the department of gastroenterology, KGMU Study Centre: Department of Gastroenterology, King George Medical University Lucknow Duration of the study: 6 months after the ethical approval
Sample Size Calculation:
Primary Outcome:
The primary endpoint is re-bleeding during hospitalization and at 6 weeks.
Standard Statistical Assumptions:
Expected re-bleeding rate in the control group (no albumin): 30% Expected reduction with intervention (albumin): 15% Significance level (α): 0.05 Power (1-β): 0.8
Formula for Binary Outcomes (Re-bleeding or No Re-bleeding):
n=(〖〖(Z〗_(∝/2)+Z_β)〗^2×[p_1 (1-p_1 )+p_2 (1-p_2 )])/(p_1-p_2 )^2
Where:
p1=0.30 (control event rate) p2=0.15 (intervention event rate) Zα/2=1.96 (for 95% confidence) Zβ=0.84 (for 80% power) Adding an attrition of minimum to 5% (0.05), the sample size for study obtained was that of 126 patients that is 63 patients in each arm. But for feasibility purposes it was rounded off to achieve a final sample size of 60 patients randomly allocated in each arm.
- Conditions
- Acute Variceal Bleeding, Cirrhosis
- Being tested
- Albumin
- Keywords
- albumin, acute variceal bleed, cirrhosis, Albumin in acute variceal bleeding
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminDrug
Also called Albumin in acute variceal bleed
All the participants with acute variceal bleed will be given albumin along with standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | All the participants with acute variceal bleed will be given albumin along with standard treatment Receives: Drug: Albumin |
| Comparator | No intervention | This comparator group will not receive the drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-bleeding rate
All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy.
The intervention planned is administration of Albumin 40 mg/day and in comparison group only standard treatment will be given Re-bleeding rate in hospital and at six weeks will be measured. Time phrame is six weeks from the event.
Measured: Six weeks (Baveno VII Consensus)
In hospital mortality
All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy.
The intervention planned is administration of Albumin 40 mg per day and in comparison group only standard treatment will be given In hospital mortality in both groups will be measured Time frame is six weeks
Measured: From enrollment to death or discharge, other outcome is measured in six weeks
Secondary outcomes (2)
Mortality
All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy.
The intervention planned is administration of Albumin 40 mg/day and in comparison group only standard treatment will be given Mortality rate at 42 days will be measured
Measured: From enrollment to 42 days (Baveno VII Consensus)
Need for rescue therapy
All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy.
The intervention planned is administration of Albumin 40 mg/day and in comparison group only standard treatment will be given Need for rescue therapy rate will be measured during hospitalization
Measured: From hospitalization to need for rescue therapy within 42 days of enrollment (Baveno VII Consensus)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (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 Acute Variceal BleedingStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King George's Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumit Rungta, King George's Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395141
- Sponsor's protocol ID
- 1098/Ethics/2025
- Acronym
- ALB-AVB
- Status last verified
- Feb 2026
- First submitted
- 24 Nov 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
PubMed 35120736Wang Z, Xie YW, Lu Q, Yan HL, Liu XB, Long Y, Zhang X, Yang JL. The impact of albumin infusion on the risk of rebleeding and in-hospital mortality in cirrhotic patients admitted for acute gastrointestinal bleeding: a retrospective study of a single institute. BMC Gastroenterol. 2020 Jun 23;20(1):198. doi: 10.1186/s12876-020-01337-5.
PubMed 32576140Sarin SK, Kumar A, Angus PW, Baijal SS, Baik SK, Bayraktar Y, Chawla YK, Choudhuri G, Chung JW, de Franchis R, de Silva HJ, Garg H, Garg PK, Helmy A, Hou MC, Jafri W, Jia JD, Lau GK, Li CZ, Lui HF, Maruyama H, Pandey CM, Puri AS, Rerknimitr R, Sahni P, Saraya A, Sharma BC, Sharma P, Shiha G, Sollano JD, Wu J, Xu RY, Yachha SK, Zhang C; Asian Pacific Association for the Study of the Liver (APASL) Working Party on Portal Hypertension. Diagnosis and management of acute variceal bleeding: Asian Pacific Association for Study of the Liver recommendations. Hepatol Int. 2011 Jun;5(2):607-24. doi: 10.1007/s12072-010-9236-9. Epub 2011 Feb 19.
PubMed 21484145Guevara M, Terra C, Nazar A, Sola E, Fernandez J, Pavesi M, Arroyo V, Gines P. Albumin for bacterial infections other than spontaneous bacterial peritonitis in cirrhosis. A randomized, controlled study. J Hepatol. 2012 Oct;57(4):759-65. doi: 10.1016/j.jhep.2012.06.013. Epub 2012 Jun 23.
PubMed 22732511Cheng HC, Chang WL, Chen WY, Tsai YC, Yeh YC, Sheu BS. Intravenous albumin shortens the duration of hospitalization for patients with hypoalbuminemia and bleeding peptic ulcers: a pilot study. Dig Dis Sci. 2013 Nov;58(11):3232-41. doi: 10.1007/s10620-013-2821-8. Epub 2013 Aug 11.
PubMed 23934414Artigas A, Wernerman J, Arroyo V, Vincent JL, Levy M. Role of albumin in diseases associated with severe systemic inflammation: Pathophysiologic and clinical evidence in sepsis and in decompensated cirrhosis. J Crit Care. 2016 Jun;33:62-70. doi: 10.1016/j.jcrc.2015.12.019. Epub 2015 Dec 29.
PubMed 26831575Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.
PubMed 30905652
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin in Acute Variceal Bleeding: A Randomized Controlled Trial: ALB-AVB Trial
- ClinicalTrials.gov ID
- NCT07395141
- Acronym / sponsor ID
- ALB-AVB / 1098/Ethics/2025
- Conditions
- Acute Variceal Bleeding, Cirrhosis
- Keywords
- albumin, acute variceal bleed, cirrhosis, Albumin in acute variceal bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King George's Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 9 Feb 2026 (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.
The objective of this randomized control clinical trial is to learn the role of albumin in patients with acute variceal bleed. The trial will include all adult patients with acute variceal bleeding and cirrhosis presenting to Medical Gastroenterology department at KGMU, Lucknow, U.P. India, will include patients with age between 18-70 years and all gender.
The primary endpoint will be re-bleeding during hospitalization and at 6 weeks. Participants will be randomized in two groups, the intervention group will receive albumin for 3 days along with standard treatment and comparison group will receive on standard treatment.
Detailed description
Albumin in acute variceal bleeding: A randomized controlled trial: ALB-AVB Trial
Introduction:
Albumin has been found to reduce mortality in patients with acute variceal bleeding in retrospective trials. However, there is no prospective data on this issue. We aim to conduct a randomized controlled trial on the role of albumin in patients with acute variceal bleeding.
Review of the literature Acute variceal bleeding is an important decompensating event in patients with cirrhosis. It is associated with 20-30% mortality in six weeks. Standard therapy with splanchnic vasoconstrictors and endoscopic band ligation is the mainstay of treatment. Previous studies have shown that albumin may decrease the mortality and re-bleeding rate in patients with AVB, however, there is no prospective data on this.
Apart from its oncotic properties albumin has different pleiotropic effects in patients with cirrhosis. It is an anti-oxidant and also binds to cytokines. Its anti-inflammatory property is responsible for reducing portal pressure and the risk of rebleeding. Currently, albumin is used in patients with acute kidney injury, spontaneous bacterial peritonitis and during large-volume paracentesis. There is also a theoretical risk of an increase in portal pressure in patients receiving albumin. The role of albumin in AVB is largely unknown. The current recommendation does not support its use in AVB however there is no strong evidence against it too. Currently, albumin has been shown to decrease mortality and decompensation in patients with cirrhosis. Large retrospective data from China have shown that albumin infusion is associated with reduced risk of rebleeding and mortality. In that study IV albumin of 40 grams/ day was associated with reduced mortality in patients with CTP-C cirrhosis. A perfectly designed RCT is warranted to explore the role of albumin in ABV.
Aim of the study:
To explore the role of albumin in patients with AVB. Study Methodology: It will be a randomised controlled trial conducted in the department of gastroenterology, KGMU Study Centre: Department of Gastroenterology, King George Medical University Lucknow Duration of the study: 6 months after the ethical approval
Sample Size Calculation:
Primary Outcome:
The primary endpoint is re-bleeding during hospitalization and at 6 weeks.
Standard Statistical Assumptions:
Expected re-bleeding rate in the control group (no albumin): 30% Expected reduction with intervention (albumin): 15% Significance level (α): 0.05 Power (1-β): 0.8
Formula for Binary Outcomes (Re-bleeding or No Re-bleeding):
n=(〖〖(Z〗_(∝/2)+Z_β)〗^2×[p_1 (1-p_1 )+p_2 (1-p_2 )])/(p_1-p_2 )^2
Where:
p1=0.30 (control event rate) p2=0.15 (intervention event rate) Zα/2=1.96 (for 95% confidence) Zβ=0.84 (for 80% power) Adding an attrition of minimum to 5% (0.05), the sample size for study obtained was that of 126 patients that is 63 patients in each arm. But for feasibility purposes it was rounded off to achieve a final sample size of 60 patients randomly allocated in each arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: AlbuminAll the participants with acute variceal bleed will be given albumin along with standard treatment |
| Comparator | No intervention | –This comparator group will not receive the drug. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients with acute variceal bleeding and cirrhosis presenting to Medical Gastroenterology department at KGMU, Lucknow, U.P. India.
Key exclusion criteria (10 listed)
- Age < 18 years and > 70 years
- Patients with portal vein thrombosis
- Hepatocellular carcinoma
- Non-cirrhotic portal fibrosis
- Extrahepatic portal vein thrombosis
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: Albumin in acute variceal bleedAll the participants with acute variceal bleed will be given albumin along with standard treatment | Drug | Intervention Arm |
Primary outcome
Re-bleeding rate
Time frame: Six weeks (Baveno VII Consensus)
All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy. The intervention planned is administration of Albumin 40 mg/day and in comparison group only standard treatment will be given Re-bleeding rate in hospital and at six weeks will be measured. Time phrame is six weeks from the event.
In hospital mortality
Time frame: From enrollment to death or discharge, other outcome is measured in six weeks
All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy. The intervention planned is administration of Albumin 40 mg per day and in comparison group only standard treatment will be given In hospital mortality in both groups will be measured Time frame is six weeks
2 secondary outcomes
Mortality
Time frame: From enrollment to 42 days (Baveno VII Consensus)
Need for rescue therapy
Time frame: From hospitalization to need for rescue therapy within 42 days of enrollment (Baveno VII Consensus)
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 9 Feb 2026.
- Results publication: PubMed 35120736de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
- Results publication: PubMed 32576140Wang Z, Xie YW, Lu Q, Yan HL, Liu XB, Long Y, Zhang X, Yang JL. The impact of albumin infusion on the risk of rebleeding and in-hospital mortality in cirrhotic patients admitted for acute gastrointestinal bleeding: a retrospective study of a single institute. BMC Gastroenterol. 2020 Jun 23;20(1):198. doi: 10.1186/s12876-020-01337-5.
- Results publication: PubMed 21484145Sarin SK, Kumar A, Angus PW, Baijal SS, Baik SK, Bayraktar Y, Chawla YK, Choudhuri G, Chung JW, de Franchis R, de Silva HJ, Garg H, Garg PK, Helmy A, Hou MC, Jafri W, Jia JD, Lau GK, Li CZ, Lui HF, Maruyama H, Pandey CM, Puri AS, Rerknimitr R, Sahni P, Saraya A, Sharma BC, Sharma P, Shiha G, Sollano JD, Wu J, Xu RY, Yachha SK, Zhang C; Asian Pacific Association for the Study of the Liver (APASL) Working Party on Portal Hypertension. Diagnosis and management of acute variceal bleeding: Asian Pacific Association for Study of the Liver recommendations. Hepatol Int. 2011 Jun;5(2):607-24. doi: 10.1007/s12072-010-9236-9. Epub 2011 Feb 19.
- Results publication: PubMed 22732511Guevara M, Terra C, Nazar A, Sola E, Fernandez J, Pavesi M, Arroyo V, Gines P. Albumin for bacterial infections other than spontaneous bacterial peritonitis in cirrhosis. A randomized, controlled study. J Hepatol. 2012 Oct;57(4):759-65. doi: 10.1016/j.jhep.2012.06.013. Epub 2012 Jun 23.
- Results publication: PubMed 23934414Cheng HC, Chang WL, Chen WY, Tsai YC, Yeh YC, Sheu BS. Intravenous albumin shortens the duration of hospitalization for patients with hypoalbuminemia and bleeding peptic ulcers: a pilot study. Dig Dis Sci. 2013 Nov;58(11):3232-41. doi: 10.1007/s10620-013-2821-8. Epub 2013 Aug 11.
- Results publication: PubMed 26831575Artigas A, Wernerman J, Arroyo V, Vincent JL, Levy M. Role of albumin in diseases associated with severe systemic inflammation: Pathophysiologic and clinical evidence in sepsis and in decompensated cirrhosis. J Crit Care. 2016 Jun;33:62-70. doi: 10.1016/j.jcrc.2015.12.019. Epub 2015 Dec 29.
- Results publication: PubMed 30905652Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.
- https://clinicaltrials.gov/study/NCT03451292Link provided by the sponsor.
- https://www.medrxiv.org/content/10.1101/2024.06.12.24308846v1.fullLink provided by the sponsor.
- https://pubmed.ncbi.nlm.nih.gov/22732511/Link provided by the sponsor.
- https://pubmed.ncbi.nlm.nih.gov/23934414/Link provided by the sponsor.
- https://pubmed.ncbi.nlm.nih.gov/21484145/Link provided by the sponsor.
- https://pubmed.ncbi.nlm.nih.gov/32576140/Link provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albumin in people with Acute Variceal Bleeding and Cirrhosis, run by King George's Medical University at 1 site in India.
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 1 inclusion and 10 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: opening soon, as of the sponsor's last update on 9 Feb 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Dr Sumit Rungta, DM- Medical Gastroenterology (+919935537944, drsumitrungta79@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-bleeding rate (time frame: Six weeks (Baveno VII Consensus)). 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 NCT07395141, 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 9 Feb 2026.