| CTRI Number |
CTRI/2025/01/079782 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Plasmapheresis (biological procedure) in Liver Disease patients. |
|
Scientific Title of Study
|
Efficacy of Plasmapheresis in Patients of severe Drug-Induced Liver Injury (DILI) with underlying chronic liver disease: An open labelled RCT. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| None |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khushboo Yadav |
| Designation |
Senior Resident,Department of hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
ky29277@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shasthry S M |
| Designation |
Additional Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
shasthry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shasthry S M |
| Designation |
Additional Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
shasthry@gmail.com |
|
|
Source of Monetary or Material Support
|
| ILBS,D-1,Vasant Kunj,New Delhi-PIN CODE-110070,India. |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
D-1,Vasant Kunj,New Delhi-110070 |
| 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 Khushboo Yadav |
Institute of Liver and Biliary Sciences |
Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
New Delhi
DELHI |
01146300000
ky29277@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PLEX with SMT |
Frequency: High Volume Plex with minimum 3 sessions on alternate days along with Standard treatment.
Route: intravenous
Duration: Minimum 3 sessions |
| Comparator Agent |
Standard Medical treatment |
Standard Medical treatment
Frequency: Daily
Route:Intravenoue
Duration 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18-75 years with previously known or unknown underlying CLD
2. Diagnosis of DILI based causality of assessment by RECAM.
3. Severe DILI with bilirubin more than 12mg/dl or INR ore than 2, S.Bili more than 5 mg per dl
4. Consent to participate in the study (based on biopsy/imaging/or clinical criteria)
|
|
| ExclusionCriteria |
| Details |
1. Active infection
2. Contraindications to plasmapheresis (e.g., severe coagulopathy, hemodynamic instability, patients with sepsis, shock, poor PF ratio).
3. Pregnant or breastfeeding women.
4. HCC or any malignancy
5. UGI bleed, uncontrolled HE
6. Option LTx being considered
7. S. Creatinine more than 2mg/dL
8. DILI ALF
9. Alcoholic Hepatitis
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Liver Transplant free survival at the end of 30 days between two groups. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in arterial lactate levels, on lactate clearance at 0, 3, 5 days |
0, 3, 5 days |
| Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 days |
0, 3, 5,30 and 90 days |
| Reduction in von Willebrand factor levels, endothelial function, and coagulopathy at 0 and 30 day. |
0 and 30 day. |
| Changes in arterial lactate levels, on lactate clearance at 0,3 days |
0,3 days |
| Changes in the inflammatory milieu, IL6, IL10, and TNF alpha at 0 and 30 day |
0 and 30 day |
| Change in liver-related decompensation events (ascites, HE, variceal bleed) at 0, 3, 5,30, and 90 days. |
0, 3, 5,30, and 90 days |
| Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 days. |
0, 3, 5,30 and 90 days. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="6"
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 - NO
|
|
Brief Summary
|
DILI is an underdiagnosed and under appreciated causal or contributing factor to liver injury. DILI can mimics features of the entire spectrum of acute and chronic liver disease. Asia–Pacifc region is characterized by two unique features; the high prevalence of tuberculosis (TB) in the population and the ubiquitous use of traditional and complimentary medicines.Current definition of Hy’s law presents significant difficulties when dealing with patients with preexisting CLD in clinical trials. Hallmark of the hepatic manifestation in these patients is hyperbilirubinemia and coagulopathy rather than ALT elevation. Study Design Single-center, non-blinded, parallel group, randomized controlled trial. Allocation ratio between two groups: 1:1. Study population: Adults aged 18-75 years with previously known or unknown underlying CLD. Diagnosis of DILI-based causality of assessment by RECAM. Severe DILI with bilirubin > 12mg/dl or INR>2, S.Bili >5 mg/dl Consent to participate in the study (based on biopsy, imaging or clinical criteria). Study design: RCT Study period: 1 year Sample size: 96 Intervention: Patients after screening for all exclusion criteria will be randomized into either the standard treatment group or the plasma exchange group.
Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid.
|