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NCT Number: NCT07664020

Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients.

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Ursodeoxycholic acid

Drug

Tab Ursodeoxycholic acid 15mg/kg in two divided doses

Standard Medical Treatment

Other

Standard Medical Treatment

Primary outcomes

  1. Regenerated liver volume

    Time frame: Post-Operative Day 14

  2. 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)

Secondary outcomes

  1. Change in Liver Function test

    Time frame: Post-Operative Day 1 to Day 7, Day 10 and Day 14

  2. Change in Coagulation parameter

    Time frame: Post-Operative Day 1 to Day 7, Day 10 and Day 14

  3. Change in Serum levels of biomarkers.

    Time frame: Post-Operative Day 0, 2, 5 and 7

  4. Daily ascitic fluid output in drain/24hr

    Time frame: Daily till Post-Operative Day 14

  5. Total ascitic fluid output till POD-14

    Time frame: Post-Operative Day 14

  6. Bile acid receptors expression for UDCA.

    Time frame: Post-Operative Day 1

    {FXR receptor concentration (hepatocytes), TGR-5 receptor concentration (cholangiocytes) of the explant liver}

  7. Evaluation of monocyte number and function (flowcytometry)

    Time frame: Post-Operative Day 1

  8. Mitochondrial and nuclear DNA (markers of Ischemia-reperfusion injury)- flowcytometry

    Time frame: Post-Operative Day 14

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Nihar Mohapatra, MCh

CONTACT

[email protected]

01146300000

Rajguru Siwach, MS

CONTACT

[email protected]

01146300000

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients : A Placebo Controlled Randomised Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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