| CTRI Number |
CTRI/2025/02/081013 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Other (Specify) [Diet] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of plasma exchange (biological procedure) in autoimmune liver Disease. |
|
Scientific Title of Study
|
Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis. A Pilot Randomized Controlled Study. |
| 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 JGnana Kavitha |
| Designation |
Senior Resident,Department of hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3311, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
New Delhi
DELHI
110070
India |
| Phone |
09717270640 |
| Fax |
|
| Email |
drkavitha777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satender Pal Singh |
| Designation |
Assistant Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3311, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
ama.satendar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satender Pal Singh |
| Designation |
Assistant Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3311, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
ama.satendar@gmail.com |
|
|
Source of Monetary or Material Support
|
| ILBS,D-1,Vasant Kunj, New Delhi-110070 |
|
|
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 JGnana Kavitha |
Institute of Liver and Biliary Sciences |
Room No. 3311, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI |
01146300000
drkavitha777@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: K754||Autoimmune hepatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Plasma Exchange with Steroid |
For plasma Exchange
Route: Intravenous
Dose: Normal Volume Plex
Frequency: Alternate day 3 to 5 sessions
Duration: Tentative 10 days
For Steroid
Route: Oral
Dose: 60 mg per day
Frequency: Once daily
Duration: 28 days |
| Comparator Agent |
Standard Medical Treatment |
Route: Oral
Dose: 60 mg per day
Frequency: Once daily
Duration: 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-60 years
2. Acute severe autoimmune hepatitis with MELD more than 24
3. No liver transplant option less than 28 days.
4. ACLF and Non ACLF
5. Auto immune hepatitis: Diagnosis by simplified AIH score more than equals to 6
|
|
| ExclusionCriteria |
| Details |
1. Patients with Active sepsis
2. Patients with Active bleeding
3. Patients allergic to FFP and blood products
4. Patients with unstable hemodynamics ( eg BP less than 90 by 60 mmhg,HR more than 100bpm)
5. Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
6. Pregnancy related liver failure
7. Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score more than 3, or oxygen/steroid-dependent chronic obstructive pulmonary disease)
8. Refusal to participate in the study
9. Patients who are eligible to transplant
10. Patients who received steroids or on steroids last 7 days
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in AST,ALT,Bilirubin |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Liver transplant free survival at 28 days |
28 days |
| Development of adverse event due to TPE. |
28 days |
| Development of clinical infection during study period. |
28 days |
| Mortality during hospital stay. |
28 days |
| Post therapy assessment in the form of clinical improvement (hepatic encephalopathy, ascites , improvement in jaundice)(both ascites and HE if present). |
28 days |
| Frequency of decompensation events on follow up period. |
28 days |
| Infections at 28 days. |
28 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/03/2025 |
| 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="2"
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
|
- Study population: Patients presenting with severe autoimmune hepatitis and MELD>24 with no liver transplant option. - - Study design: A Pilot Randomised control trial - Study period: 2 year - Sample size: - There is no studies of PE in severe AIH, assuming effect of PE in ACLF group - Survival rate with plasma exchange was assumed to be 60 % and 20 % without PE. - Further assuming 95% power and alpha 5 %. - We need to enroll 46 cases i.e. 23 in each group - Further assuming % defaulter rate, it is further decided to enroll 25 cases in each group. - Patients will be randomly allocated in 2 groups by 1:1 block randomisation and will be implemented by IWRS facility taking block size 10. - 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. - Interim analysis would be done to check efficacy and safety of TPE in severe autoimmune hepatitis.
- Adverse effects: Therapeutic Plasma Exchange is associated with risk of adverse events like infections,Fluid overload or circulatory insufficiency, Hypersensitivity to blood products. - Stopping rule: Study will be stopped in case of life- threatening events occur in patient after randomisation
|