NCT07664020

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Nov 2027

First Submitted

Initial submission to the registry

June 6, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

June 18, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

June 23, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

June 6, 2026

Last Update Submit

June 17, 2026

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (2)

  • Regenerated liver volume

    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)

    Post-Operative Day 14

Secondary Outcomes (8)

  • Change in Liver Function test

    Post-Operative Day 1 to Day 7, Day 10 and Day 14

  • Change in Coagulation parameter

    Post-Operative Day 1 to Day 7, Day 10 and Day 14

  • Change in Serum levels of biomarkers.

    Post-Operative Day 0, 2, 5 and 7

  • Daily ascitic fluid output in drain/24hr

    Daily till Post-Operative Day 14

  • Total ascitic fluid output till POD-14

    Post-Operative Day 14

  • +3 more secondary outcomes

Study Arms (2)

Ursodeoxycholic acid+standard medical treatment

EXPERIMENTAL
Drug: Ursodeoxycholic acidOther: Standard Medical Treatment

Placebo+standard medical treatment

ACTIVE COMPARATOR
Other: Standard Medical Treatment

Interventions

Ursodeoxycholic acidDRUG

Tab Ursodeoxycholic acid 15mg/kg in two divided doses

Ursodeoxycholic acid+standard medical treatment
Standard Medical TreatmentOTHER

Standard Medical Treatment

Placebo+standard medical treatmentUrsodeoxycholic acid+standard medical treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ILBS

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Central Study Contacts

Rajguru Siwach, MS

CONTACT

01146300000rajgurusiwach@gmail.com

Dr Nihar Mohapatra, MCh

CONTACT

01146300000nihar0310@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2026

First Posted

June 23, 2026

Study Start

June 18, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

June 23, 2026

Record last verified: 2026-05

Locations

IN(1)