Chronic Liver DiseaseNCT07664020
Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients.
A study testing Ursodeoxycholic acid and Standard Medical Treatment in people with Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
This placebo controlled randomized control study aims to analyze the effect of UDCA supplementation on liver regeneration in Living Donor Liver Transplant (LDLT) recipients. All eligible LDLT recipients during the study period will be included in the study and randomized into two groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- Ursodeoxycholic acid and Standard Medical Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIndia
- Study dates
- 18 Jun 2026to 1 Nov 2027
- Phase
- Interventional
- 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 Living Donor Liver Transplant (LDLT) Recipients in ILBS from ethical board clearance to December 2027 in the Department of HPB Surgery and Liver Transplantation, Institute of Liver and Biliary Sciences
Who cannot join
- Unwillingness to participate
- Hypersensitivity to UDCA
- Patients receiving UDCA pre-operatively within 1 month of liver transplant (PBC and patients of overlap syndrome)
- Right posterior and left laterals grafts
- Emergency 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
ILBS
New Delhi, National Capital Territory of Delhi, 110070
Rajguru Siwach, MS, 01146300000, rajgurusiwach@gmail.com
About this study
Official title: Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients : A Placebo Controlled Randomised Trial
This placebo controlled randomized control study aims to analyze the effect of UDCA supplementation on liver regeneration in Living Donor Liver Transplant (LDLT) recipients. All eligible LDLT recipients during the study period will be included in the study and randomized into two groups. One group will receive Tab UDCA starting atleast 10 days pre-operatively and continued till post-operative day 10 and the other group will receive placebo. UDCA will be given at a dose of 15mg/kg per day in two divided doses. Recipients who are not willing to participate in the study, have hypersensitivity to UDCA will be excluded from the study. Pediatrics recipients and acute liver failure recipients will also be excluded.
Pre- operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system (PACS). The enrolled subjects will be followed up till for a period of 14 days after the transplant till NCCT Abdomen is done and regenerated liver volumes are analyzed. The anatomic(volumetric), functional(liver function tests) and regenerative biomarkers (HGF, TNF-Alpha, IL6, TGF-Beta1) will be compared between the two groups. Evaluation of incidence of Early Allograft Dysfunction (EAD) as per Modified Olthoff criteria1 will be done between the two groups. FXR receptor concentration (hepatocytes) and TGR-5 receptor concentration (cholangiocytes) will be seen in the explant liver along with evaluation of monocyte number and function and mitochondrial and nuclear DNA.
- Conditions
- Chronic Liver Disease
- Being tested
- Ursodeoxycholic acid, Standard Medical Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acidDrug
Tab Ursodeoxycholic acid 15mg/kg in two divided doses
Standard Medical TreatmentOther
Standard Medical Treatment
| Study group | Role | What they receive |
|---|---|---|
| Ursodeoxycholic acid+standard medical treatment | Experimental | Not described Receives: Drug: Ursodeoxycholic acid; Other: Standard Medical Treatment |
| Placebo+standard medical treatment | Active comparator | Not described Receives: Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regenerated liver volume
Measured: Post-Operative Day 14
Regeneration Liver Indices • Percentage restoration of SLV (Standard liver volume) • Regeneration index (%) : (Regenerated liver volume-GW/GW)x100 • Kinetic growth rate (volume in CC/Day)
Regeneration Liver Indices is defined by-
- Percentage restoration of SLV (Standard liver volume)
- Regeneration index (percentages) : (Regenerated liver volume-GW/GW)x100
- Kinetic growth rate (volume in CC/Day)
Measured: Post-Operative Day 14
Secondary outcomes (8)
Change in Liver Function test
Measured: Post-Operative Day 1 to Day 7, Day 10 and Day 14
Change in Coagulation parameter
Measured: Post-Operative Day 1 to Day 7, Day 10 and Day 14
Change in Serum levels of biomarkers.
Measured: Post-Operative Day 0, 2, 5 and 7
Daily ascitic fluid output in drain/24hr
Measured: Daily till Post-Operative Day 14
Total ascitic fluid output till POD-14
Measured: Post-Operative Day 14
Bile acid receptors expression for UDCA.
{FXR receptor concentration (hepatocytes), TGR-5 receptor concentration (cholangiocytes) of the explant liver}
Measured: Post-Operative Day 1
Evaluation of monocyte number and function (flowcytometry)
Measured: Post-Operative Day 1
Mitochondrial and nuclear DNA (markers of Ischemia-reperfusion injury)- flowcytometry
Measured: Post-Operative Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start18 Jun 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 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
- NCT07664020
- Sponsor's protocol ID
- IEC/2026/126/MA01
- Status last verified
- May 2026
- First submitted
- 6 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients : A Placebo Controlled Randomised Trial
- ClinicalTrials.gov ID
- NCT07664020
- Acronym / sponsor ID
- IEC/2026/126/MA01
- Conditions
- Chronic Liver Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 18 Jun 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 23 Jun 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.
This placebo controlled randomized control study aims to analyze the effect of UDCA supplementation on liver regeneration in Living Donor Liver Transplant (LDLT) recipients. All eligible LDLT recipients during the study period will be included in the study and randomized into two groups. One group will receive Tab UDCA starting atleast 10 days pre-operatively and continued till post-operative day 10 and the other group will receive placebo. UDCA will be given at a dose of 15mg/kg per day in two divided doses. Recipients who are not willing to participate in the study, have hypersensitivity to UDCA will be excluded from the study. Pediatrics recipients and acute liver failure recipients will also be excluded.
Pre- operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system (PACS). The enrolled subjects will be followed up till for a period of 14 days after the transplant till NCCT Abdomen is done and regenerated liver volumes are analyzed. The anatomic(volumetric), functional(liver function tests) and regenerative biomarkers (HGF, TNF-Alpha, IL6, TGF-Beta1) will be compared between the two groups. Evaluation of incidence of Early Allograft Dysfunction (EAD) as per Modified Olthoff criteria1 will be done between the two groups. FXR receptor concentration (hepatocytes) and TGR-5 receptor concentration (cholangiocytes) will be seen in the explant liver along with evaluation of monocyte number and function and mitochondrial and nuclear DNA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ursodeoxycholic acid+standard medical treatment | Experimental | Drug: Ursodeoxycholic acid, Other: Standard Medical Treatment |
| Placebo+standard medical treatment | Active comparator | Other: Standard Medical Treatment |
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 Living Donor Liver Transplant (LDLT) Recipients in ILBS from ethical board clearance to December 2027 in the Department of HPB Surgery and Liver Transplantation, Institute of Liver and Biliary Sciences
Key exclusion criteria (5 listed)
- Unwillingness to participate
- Hypersensitivity to UDCA
- Patients receiving UDCA pre-operatively within 1 month of liver transplant (PBC and patients of overlap syndrome)
- Right posterior and left laterals grafts
- Emergency 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 |
|---|---|---|
| Ursodeoxycholic acidTab Ursodeoxycholic acid 15mg/kg in two divided doses | Drug | Ursodeoxycholic acid+standard medical treatment |
| Standard Medical TreatmentStandard Medical Treatment | Other | Placebo+standard medical treatment, Ursodeoxycholic acid+standard medical treatment |
Primary outcome
Regenerated liver volume
Time frame: Post-Operative Day 14
Regeneration Liver Indices • Percentage restoration of SLV (Standard liver volume) • Regeneration index (%) : (Regenerated liver volume-GW/GW)x100 • Kinetic growth rate (volume in CC/Day)
Time frame: Post-Operative Day 14
Regeneration Liver Indices is defined by- * Percentage restoration of SLV (Standard liver volume) * Regeneration index (percentages) : (Regenerated liver volume-GW/GW)x100 * Kinetic growth rate (volume in CC/Day)
8 secondary outcomes
Change in Liver Function test
Time frame: Post-Operative Day 1 to Day 7, Day 10 and Day 14
Change in Coagulation parameter
Time frame: Post-Operative Day 1 to Day 7, Day 10 and Day 14
Change in Serum levels of biomarkers.
Time frame: Post-Operative Day 0, 2, 5 and 7
Daily ascitic fluid output in drain/24hr
Time frame: Daily till Post-Operative Day 14
Total ascitic fluid output till POD-14
Time frame: Post-Operative Day 14
Bile acid receptors expression for UDCA.
Time frame: Post-Operative Day 1
Evaluation of monocyte number and function (flowcytometry)
Time frame: Post-Operative Day 1
Mitochondrial and nuclear DNA (markers of Ischemia-reperfusion injury)- flowcytometry
Time frame: Post-Operative Day 14
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 23 Jun 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?
A study testing Ursodeoxycholic acid and Standard Medical Treatment in people with 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 1 inclusion and 5 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 23 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 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 Rajguru Siwach, MS (01146300000, rajgurusiwach@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regenerated liver volume (time frame: Post-Operative Day 14). 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?
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 23 Jun 2026.