| CTRI Number |
CTRI/2025/08/092415 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of a drug called Pentoxifylline to improve Liver growth in patients after Liver Transplantation
|
|
Scientific Title of Study
|
Role of Perioperative Pentoxifylline on Liver Regeneration in Living Donor Liver Transplantation
|
| Trial Acronym |
PENTOX study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Susan Paulin |
| Designation |
CONSULTANT |
| Affiliation |
Dr Rela Institute And Medical Centre |
| Address |
Olympia grande apartments, Chennai
ICU OFFICE
third floor
Department of Liver transplantation and critical care
Dr. Rela institute and medical centre
Chrompet -44
Kancheepuram
TAMIL NADU
600043
India |
| Phone |
9994519890 |
| Fax |
|
| Email |
susanvercetti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Susan Paulin |
| Designation |
CONSULTANT |
| Affiliation |
Dr Rela Institute And Medical Centre |
| Address |
Olympia grande apartments, Chennai
ICU OFFICE
third floor
Department of Liver transplantation and critical care
Dr. Rela institute and medical centre
Chrompet -44
TAMIL NADU
600043
India |
| Phone |
9994519890 |
| Fax |
|
| Email |
susanvercetti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Susan Paulin |
| Designation |
CONSULTANT |
| Affiliation |
Dr Rela Institute And Medical Centre |
| Address |
Olympia grande apartments, Chennai
ICU OFFICE
third floor
Department of Liver transplantation and critical care
Dr. Rela institute and medical centre
Chrompet -44
TAMIL NADU
600043
India |
| Phone |
9994519890 |
| Fax |
|
| Email |
susanvercetti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rela Institute and medical centre
ICU OFFICE
third floor
Department of Liver transplantation and critical care
Dr. Rela institute and medical centre
Chrompet -44 |
|
|
Primary Sponsor
|
| Name |
Dr Rela Institute and Medical centre |
| Address |
ICU OFFICE
third floor
Department of Liver transplantation and critical care
Dr. Rela institute and medical centre
Chrompet -44
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Susan Paulin |
Dr. Rela Institute and medical centre |
ICU Office in 3 rd floor, No. 3 CLC works road, Shankar Nagar, Chrompet. 600044
Kancheepuram
TAMIL NADU |
9994519890
susanvercetti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K70-K77||Diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral pentoxiphylline 400 mg thrice daily |
Oral pentoxiphylline will be started 3 days prior to Liver transplantation and continued till postoperative day 7 |
| Comparator Agent |
Placebo |
Placebo tablets will be given for control group from 3 days prior to liver transplantation till postoperative day 7 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
all Living donor liver transplant recipients with an expected graft recipient weight ratio less than 0.8 |
|
| ExclusionCriteria |
| Details |
Unwilling for participation, acute liver failure and acute on chronic liver failure, MELD score more than 30, chronic kidney disease, cardiac dysfunction such as arrhythmia, heart blocks and coronary artery disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the liver regeneration at POD 8 which will measured by non-contrast three-dimensional computed tomography/magnetic resonance imaging |
till 8 th postoperative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of the incidence of small for size syndrome
2. Assessment of degree of postoperative liver injury by daily measurement of postoperative serum transaminases, bilirubin and prothrombin time (PT)/international normalized ratio (INR) until POD 7
3. Assessment of other recovery parameters such as length of ICU and hospital stay, Clavien Dindo classification of surgical complications
4. Assessment of adverse drug events directly attributable to the PTX |
till 8th postoperative day |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [scarf.69-splice@icloud.com].
- For how long will this data be available start date provided 01-07-2026 and end date provided 01-06-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
After written informed consent, a pilot study will be conducted with 10 patients to assess for feasibility and drug safety following which the double-blinded randomized control trial (DB- RCT) will be carried out. For the DB- RCT, the patients will be randomized using computer generated randomization charts in to two groups: the Pentox group (Group I) and the Placebo group (Group C). The randomization and drug delivery will be done by independent personnel (Third party - not related to the study). The patients in the Pentox arm will receive Oral pentoxifylline 24 hours before LDLT at doses upto 15mg/kg in three divided doses and then continued till 7 days postoperatively. The control group will receive color-matched multivitamin tablets as placebo. Monitoring for drug related adverse events described according to the product monograph will be closely carried out. These include: cardiovascular system: Arrhythmias, unexplained tachycardia; Central nervous system: Dizziness, headache, somnolence; Gastrointestinal symptoms: Nausea, vomiting, heartburn, constipation.
|