| CTRI Number |
CTRI/2025/02/081072 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Dabigatran drug versus Enoxaparin drug in Liver Cirrhosis (Disease). |
|
Scientific Title of Study
|
Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis: A 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 Sarthak Chanana |
| Designation |
Senior Resident,Department of hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3315, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
xs2sarthak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Rajan |
| Designation |
Associate Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3315, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
rajanvf40@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Rajan |
| Designation |
Associate Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3315, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
rajanvf40@gmail.com |
|
|
Source of Monetary or Material Support
|
| ILBS,D-1,Vasant Kunj, New Delhi-110070,India. |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
D-1,Vasant Kunj, New Delhi-110070,India. |
| 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 Sarthak Chanana |
Institute of Liver and Biliary Sciences |
Room No. 3315, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI |
01146300000
xs2sarthak@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 |
Dabigatran |
Dabigatran 150 mg BD fixed dose to be given for duration of 6 months. |
| Comparator Agent |
Enoxaparin |
Enoxaparin Treatment would be given with 1 mg per Kg (100IU per Kg) dose subcutaneous twice daily for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 18 years
2. Cirrhosis with portal vein thrombosis within 6 months of diagnosis/Symptomatic PVT/PVT in potential transplant recipient.
|
|
| ExclusionCriteria |
| Details |
1. Contraindications to anticoagulant therapy, such as active bleeding, recent major surgery, or known hypersensitivity to study medications.
2. CTP more than 10
3. Hepatocellular carcinoma
4. Tumoral PVT
5. Isolated gastric varices with red colour signs
6. Peptic ulcer disease with large ulcers
7. Pregnant or breastfeeding women
8. Thrombocytopenia (platelet count less than 50,000 per micro L)
9. Patients with concurrent acute kidney injury or chronic kidney disease stage 4 or 5
10. Those not giving consent for therapy
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Dabigatran and enoxaparin in achieving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of partial and complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups |
6 months |
| Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groups |
3 months |
| Rate of recurrence of Portal Vein Thrombosis at 12 months. |
12 months |
| Adverse events in both the groups till 6-months |
6 months |
| Change in CTP scores and MELD scores in both the groups over 12-months |
12 months |
| Variceal and non-variceal bleeding rates at 6-months and 12-months. |
12 months |
| Worsening of decompensation events and new onset decompensation events in the two study groups till 12-months. |
12 months |
| To define predictors of recanalisation at 6 months and rethrombosis at 12 months. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
08/03/2025 |
| 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="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
|
Study population: Cirrhosis with portal vein thrombosis within 6 months of diagnosis of portal vein thrombus Study design - A prospective, randomized, single center open label study Block Randomization, block size – 10 Study site - Department of Hepatology, ILBS, New Delhi from The study will be conducted on the consecutive patients with liver cirrhosis with portal vein thrombosis. Study period –1 year Monitoring and assessment - At enrollment: 1. Complete history and physical examination 2. Etiology of cirrhosis 3. Presenting symptoms 4. Severity of ascites, Jaundice 5. Pattern and number of prior decompensation 6. UGIE and variceal status 7. Complete physical evaluation 8. Hemogram, Kidney function test, Liver function test, INR 9. Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen 10. Fibroscan-liver and spleen 11. 2D-ECHO, ECG 12. AFP At follow-up (1month, 3 month, 6 month, 9 month 12month) 1. Complete history and physical examination 2. Pattern and number of decompensation 3. MELD, CTP, APRI, ALBI Score 4. Hemogram, Kidney function test, Liver function test, INR 5. Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen
|