Chronic Liver DiseaseNCT07270809
To Study the Clinical Course and Outcomes of Non-electively Hospitalised Patients of Chronic Liver Disease (CLD) With Hepatic or Extra-hepatic Predominant Organ Failure(s) at 6 Months.
An observational study of Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Title - To study the clinical course and outcomes of non-electively hospitalised patients of chronic liver disease (CLD) with Hepatic or Extra-hepatic predominant organ failure(s) at 6 months. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Liver Disease
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 15 Apr 2025to 31 Dec 2026
- Phase
- Observational
- 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
Study population: Chronic Liver Disease with or without cirrhosis, non-electively hospitalized with decompensation, hepatic and/or extra-hepatic organ failure with/without prior decompensation.
Who may be able to join
- Age 18-70 years
- CLD with or without cirrhosis with 1st or subsequent admissions for decompenasation and irrespective of any prior decompensation
- Non-electively hospitalized
Who cannot join
- HCC
- NCPF/EHPVO
- Pregnancy
- Post-Liver transplant
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, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Amanjot Kaur, MD, 01146300000, amanjotbahri@gmail.com
About this study
Title - To study the clinical course and outcomes of non-electively hospitalised patients of chronic liver disease (CLD) with Hepatic or Extra-hepatic predominant organ failure(s) at 6 months.
Summary - ACLF is a condition where acute insult leading to worsening liver failure with or without extra-hepatic failure leads to a high short-term mortality. However, the presence of cirrhosis, prior decompensation, non-hepatic/systemic acute insult, organ failure and treatment are different in different part of the world. This is due to in-homogenous patient cohort. The current study was planned for all patients of CLD, who were non-electively hospitalized and were followed up for long-term to identify the differences in clinical course, acute insult, organ failure, therapy and outcome in relation to liver failure with or without extra-hepatic organic failure. In the study the laboratory, clinical parameters, inflammatory and regenerative markers will be evaluated as a marker of disease progression, reversal, recompensation or regression. This will enable us to differentiate the ACLF between east and west, guide us for defining the natural course of CLD with failure.
- Conditions
- Chronic Liver Disease
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Chronic Liver Disease (CLD) With Hepatic Predominant Organ Failure | Not described Receives: Other: No Intervention | |
| Chronic Liver Disease (CLD) With Extra-hepatic Predominant Organ Failure | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or liver transplant at 6 months follow up.
Measured: 6 months
Secondary outcomes (2)
Recovery as per disease severity scores, i.e- decrease in MELD ≥5 and CTP ≥3
Measured: 6 months
Organ dysfunction and organ failures
Measured: day 28, day 90, day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start15 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270809
- Sponsor's protocol ID
- ILBS-CLD-66
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Clinical Course and Outcomes of Non-electively Hospitalised Patients of Chronic Liver Disease (CLD) With Hepatic or Extra-hepatic Predominant Organ Failure(s) at 6 Months.
- ClinicalTrials.gov ID
- NCT07270809
- Acronym / sponsor ID
- ILBS-CLD-66
- Conditions
- Chronic Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Dec 2025 (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.
Title - To study the clinical course and outcomes of non-electively hospitalised patients of chronic liver disease (CLD) with Hepatic or Extra-hepatic predominant organ failure(s) at 6 months.
Summary - ACLF is a condition where acute insult leading to worsening liver failure with or without extra-hepatic failure leads to a high short-term mortality. However, the presence of cirrhosis, prior decompensation, non-hepatic/systemic acute insult, organ failure and treatment are different in different part of the world. This is due to in-homogenous patient cohort. The current study was planned for all patients of CLD, who were non-electively hospitalized and were followed up for long-term to identify the differences in clinical course, acute insult, organ failure, therapy and outcome in relation to liver failure with or without extra-hepatic organic failure. In the study the laboratory, clinical parameters, inflammatory and regenerative markers will be evaluated as a marker of disease progression, reversal, recompensation or regression. This will enable us to differentiate the ACLF between east and west, guide us for defining the natural course of CLD with failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Liver Disease (CLD) With Hepatic Predominant Organ Failure | – | Other: No Intervention |
| Chronic Liver Disease (CLD) With Extra-hepatic Predominant Organ Failure | – | Other: No Intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Liver Disease with or without cirrhosis, non-electively hospitalized with decompensation, hepatic and/or extra-hepatic organ failure with/without prior decompensation.
Key inclusion criteria (3 listed)
- Age 18-70 years
- CLD with or without cirrhosis with 1st or subsequent admissions for decompenasation and irrespective of any prior decompensation
- Non-electively hospitalized
Key exclusion criteria (4 listed)
- HCC
- NCPF/EHPVO
- Pregnancy
- Post-Liver transplant
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 |
|---|---|---|
| No InterventionNo Intervention | Other | Chronic Liver Disease (CLD) With Extra-hepatic Predominant Organ Failure, Chronic Liver Disease (CLD) With Hepatic Predominant Organ Failure |
Primary outcome
Death or liver transplant at 6 months follow up.
Time frame: 6 months
2 secondary outcomes
Recovery as per disease severity scores, i.e- decrease in MELD ≥5 and CTP ≥3
Time frame: 6 months
Organ dysfunction and organ failures
Time frame: day 28, day 90, day 180
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 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India 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 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 11 Aug 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.
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 Amanjot Kaur, MD (01146300000, amanjotbahri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or liver transplant at 6 months follow up. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.