Chronic Liver Disease and CirrhosisNCT07685353
Influence of Donor and Recipient Genetic Polymorphisms on Graft Steatosis After Liver Transplant
An observational study of Chronic Liver Disease and Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
MASH (Metabolic Dysfunction-associated Steatohepatitis) is among the most common indications for liver transplantation.The metabolic syndrome persists after liver transplant and is often further exacerbated among MAFLD patients, thereby leading to recurrence of MAFLD in the allograft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease and Cirrhosis
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 7 Jul 2026to 31 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All LDLT recipients with MASH related CLD and their donors who underwent their surgery at ILBS at least 3 years prior to the onset of this study.
Who may be able to join
- All LDLT recipients with MASH related CLD and their donors who underwent their surgery at ILBS at least 3 years prior to the onset of this study.
Who cannot join
- Pediatric (<18 years)
- Transplants for ALF/ ACLF
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 and Biliary Sciences
New Delhi
Naren Mandalapu, MS, +918096006447, bearebel69@gmail.com
About this study
Official title: Influence of Donor and Recipient PNPLA3 and MBOAT7 Gene Polymorphisms on Graft Liver Steatosis After Living Donor Liver Transplant for Metabolic Dysfunction-associated Steatohepatitis (MASH) Related Cirrhosis
MASH (Metabolic Dysfunction-associated Steatohepatitis) is among the most common indications for liver transplantation.The metabolic syndrome persists after liver transplant and is often further exacerbated among MAFLD patients, thereby leading to recurrence of MAFLD in the allograft. MAFLD is a complex phenotype, dynamic interactions between both genetic and environmental factors are likely to shape disease susceptibility and progression.
Genetic and epidemiological studies, indicates strong heritability of hepatic fat content.Family studies demonstrate that first degree relatives of patients with MAFLD are at a much higher risk of the disease than the general population.Most of the data available is regarding Deceased Donor Liver Transplant and Western population.Most studies have studied single gene variant but fatty liver is a polygenic trait.No study was done exclusively in MASH recipients.
In this study we aim to study the effect of recipient and donor PNPLA3, MBOAT7 gene variations, and other clinical \& laboratory data on graft liver steatosis in liver transplant recipients. We also propose to compare the outcomes of genetically related donors vs unrelated donors, to know the influence of genetic factors vis-a-vis environmental factors.
Read the detailed description
MASH (Metabolic Dysfunction-associated Steatohepatitis) is among the most common indications for liver transplantation.The metabolic syndrome persists after liver transplant and is often further exacerbated among MAFLD patients, thereby leading to recurrence of MAFLD in the allograft. MAFLD is a complex phenotype, dynamic interactions between both genetic and environmental factors are likely to shape disease susceptibility and progression.
Genetic and epidemiological studies, indicates strong heritability of hepatic fat content.Family studies demonstrate that first degree relatives of patients with MAFLD are at a much higher risk of the disease than the general population.
PNPLA3 isoleucine to methionine substitution at position 148 is the most robust and well replicated genetic variant associated with MAFLD. MBOAT7 was recently associated with the risk of MAFLD, inflammation and fibrosis. Furthermore, it was recently linked to progression of MAFLD to HCC.
Most of the data available on donor and recipient PNPLA3 and MBOAT7 gene polymorphisms is with regards to Deceased Donor Liver Transplant and Western population. There are contradictory conclusions in different studies. Most studies have studied single gene variant but MAFLD is a polygenic trait. No study exclusively in MASH related CLD recipients. A study in the setting of LDLT gives us an opportunity to assess both genotypic and phenotypic (environmental) factors. Hence this study is being done in a high volume liver transplant center in India, in the setting of LDLT which gives us an opportunity to assess both genotypic and phenotypic (environmental) factors.
- Conditions
- Chronic Liver Disease and Cirrhosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Liver Disease | Chronic Liver Disease patients undergoing Living Donor Liver Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PNPLA3 and MBOAT7 gene polymorphisms
To assess the impact of donor and recipient PNPLA3 and MBOAT7 gene polymorphisms on the development and severity of graft steatosis following Living Donor Liver Transplantation
Measured: 3 years after Liver Transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start7 Jul 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 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 Disease and CirrhosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viniyendra Pamecha, MS, FEBS, Study director, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685353
- Sponsor's protocol ID
- IEC/2024/108/MA10
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 21 Jul 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Donor and Recipient PNPLA3 and MBOAT7 Gene Polymorphisms on Graft Liver Steatosis After Living Donor Liver Transplant for Metabolic Dysfunction-associated Steatohepatitis (MASH) Related Cirrhosis
- ClinicalTrials.gov ID
- NCT07685353
- Acronym / sponsor ID
- IEC/2024/108/MA10
- Conditions
- Chronic Liver Disease and Cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 6 Jul 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.
MASH (Metabolic Dysfunction-associated Steatohepatitis) is among the most common indications for liver transplantation.The metabolic syndrome persists after liver transplant and is often further exacerbated among MAFLD patients, thereby leading to recurrence of MAFLD in the allograft. MAFLD is a complex phenotype, dynamic interactions between both genetic and environmental factors are likely to shape disease susceptibility and progression.
Genetic and epidemiological studies, indicates strong heritability of hepatic fat content.Family studies demonstrate that first degree relatives of patients with MAFLD are at a much higher risk of the disease than the general population.Most of the data available is regarding Deceased Donor Liver Transplant and Western population.Most studies have studied single gene variant but fatty liver is a polygenic trait.No study was done exclusively in MASH recipients.
In this study we aim to study the effect of recipient and donor PNPLA3, MBOAT7 gene variations, and other clinical \& laboratory data on graft liver steatosis in liver transplant recipients. We also propose to compare the outcomes of genetically related donors vs unrelated donors, to know the influence of genetic factors vis-a-vis environmental factors.
Detailed description
MASH (Metabolic Dysfunction-associated Steatohepatitis) is among the most common indications for liver transplantation.The metabolic syndrome persists after liver transplant and is often further exacerbated among MAFLD patients, thereby leading to recurrence of MAFLD in the allograft. MAFLD is a complex phenotype, dynamic interactions between both genetic and environmental factors are likely to shape disease susceptibility and progression.
Genetic and epidemiological studies, indicates strong heritability of hepatic fat content.Family studies demonstrate that first degree relatives of patients with MAFLD are at a much higher risk of the disease than the general population.
PNPLA3 isoleucine to methionine substitution at position 148 is the most robust and well replicated genetic variant associated with MAFLD. MBOAT7 was recently associated with the risk of MAFLD, inflammation and fibrosis. Furthermore, it was recently linked to progression of MAFLD to HCC.
Most of the data available on donor and recipient PNPLA3 and MBOAT7 gene polymorphisms is with regards to Deceased Donor Liver Transplant and Western population. There are contradictory conclusions in different studies. Most studies have studied single gene variant but MAFLD is a polygenic trait. No study exclusively in MASH related CLD recipients. A study in the setting of LDLT gives us an opportunity to assess both genotypic and phenotypic (environmental) factors. Hence this study is being done in a high volume liver transplant center in India, in the setting of LDLT which gives us an opportunity to assess both genotypic and phenotypic (environmental) factors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Liver Disease | – | –Chronic Liver Disease patients undergoing Living Donor Liver Transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All LDLT recipients with MASH related CLD and their donors who underwent their surgery at ILBS at least 3 years prior to the onset of this study.
Key inclusion criteria (1 listed)
- All LDLT recipients with MASH related CLD and their donors who underwent their surgery at ILBS at least 3 years prior to the onset of this study.
Key exclusion criteria (2 listed)
- Pediatric (<18 years)
- Transplants for ALF/ ACLF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PNPLA3 and MBOAT7 gene polymorphisms
Time frame: 3 years after Liver Transplantation
To assess the impact of donor and recipient PNPLA3 and MBOAT7 gene polymorphisms on the development and severity of graft steatosis following Living Donor Liver Transplantation
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 21 Jul 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.
Viniyendra Pamecha, MS, FEBS study director
Institute of Liver and Biliary Sciences, India
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 and Cirrhosis, 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 2 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 21 Jul 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 Naren Mandalapu, MS (+918096006447, bearebel69@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PNPLA3 and MBOAT7 gene polymorphisms (time frame: 3 years after Liver Transplantation). 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 21 Jul 2026.