Liver CirrhosisNCT04433481
Efficacy and Safety of Dabigatran in Patients With Cirrhosis and Portal Vein Thrombosis
A study testing Dabigatran in people with Liver Cirrhosis and Portal Vein Thrombosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
A randomized controlled trial to study the efficacy and safety of Dabigatran in Cirrhotic patients who develop PVT.In this study the patients who meet the inclusion criteria will be randomized to either receive Dabigatran or placebo [multivitamin tablet]. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis, Portal Vein Thrombosis
- What is being tested?
- Dabigatran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jun 2020to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical / radiological /histologic diagnosis of cirrhosis [Childs A\&B - CTP<9]
- Partial / total portal vein thrombosis (chronic)
- Age- 18-70 years
- Valid consent
Who cannot join
- Age > 70 years
- Presence of active infection (<2 weeks)
- Use of anticoagulant drugs in the past 10 days
- Pregnancy
- HIV positivity
- Recent (<7 days) transfusion with blood products.
Show all 11Show fewer
- History of bleeding in last 42 days
- HCC / Other malignancy
- Chronic kidney disease [ CrCl< 30]
- Drug allergies
- PVT with cavernoma formation
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr G Srinivasa Reddy, MD, 01146300000, srinivasareddygolamari@gmail.com
About this study
Official title: Efficacy and Safety of Dabigatran in Patients With Cirrhosis and Portal Vein Thrombosis-A Randomized Placebo Controlled Trial
A randomized controlled trial to study the efficacy and safety of Dabigatran in Cirrhotic patients who develop PVT.In this study the patients who meet the inclusion criteria will be randomized to either receive Dabigatran or placebo [multivitamin tablet]. Blood samples will be taken \&Imaging will be done accordingly to notice progression or recanalization of PVT.The patients are followed up every 2 months up to 18 month .Then statistical analysis will be done to find whether the Dabigatran is efficacious in cirrhotic patients for recanalization of PVT.
Read the detailed description
Study population -All the patients of cirrhosis of liver patients visiting to ILBS and diagnosed to have non tumor portal vein thrombosis will be enrolled in the study.
Study Design - A Placebo Controlled Double Blinded RCT In this randomized controlled trial, the patients who satisfy the below inclusion and exclusion criteria will be included and they will be randomized, according to 2 groups (in total 84patients) to receive either Placebo or dabigatran 150 mg BD for 12months. These patients will be admitted to the hospital from OPD or emergency.
Study period - 1.5 years from ethics approval Intervention The patients in Group A will receive T. Dabigatran 150 mg twice a day .The patients in Group B will receive placebo [multivitamins] Monitoring and assessment At baseline, a complete history with clinical and physical examination, a record of demographic profile, standard of care biochemical investigations would be done. All included patients will be evaluated with -
- Etiology of cirrhosis
- Upper GI endoscopy
- Haemogram (including reticulocyte count)
- Coagulogram- PT/INR,APTT,TEG
- Prothrombotic profile- protein c/protein-s/AT-III/Factor V Leiden mutation/ MTHFR C677T/PROTHROMBIN G20210A/ JAK2 V617F MUTATION / Anticardiolipin Ab.
- Liver function tests, Renal function tests
- Alpha fetoprotein/PIVKA II
- USG abdomen with Doppler study
- CECT-TP or CEMRI-TP to R/O HCC or angiography when PVT diagnosis doubtful.
- HVPG+LIVER BIOPSY[optional]
- Fibro scan
- Child-Pugh score, MELD Subsequently, patients will be assessed clinically at the baseline and post-treatment every2 months till 18 months
Statistical Analysis:
The data collected will be analyzed using SPSS ver 22 by standard statistical analysis, were numerical data will be analyzed to find mean, median scores and categorical data will be analyzed using Chi square test and continuous data will be analyzed by student T test and any association will be analyzed by the univariate and multivariate analysis, log regression analysis along with ROC curve will be used and p<0.05 will be considered significant and results will be appropriately tabulated
Adverse Effects Hemorrhage - Fatal Major - intracranial, retroperitoneal, intraocular, muscle hematoma Minor TREATMENT IN CASE OF ADVERSE EFFECTS - Withdrawal of drug
Stopping rule of study Allergic reactions to drug Severe hemorrhage DIC Progression of PVT after 6 months viral reactivation leading to ACLF, acute hepatitis (viral, drug related, autoimmune flare), sepsis with severe coagulopathy
- Conditions
- Liver Cirrhosis, Portal Vein Thrombosis
- Being tested
- Dabigatran, Placebo
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabigatranDrug
- Dabigatran 150 mg twice a day
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| DABIGATRAN | Experimental | 150mg BD for 12 months Receives: Drug: Dabigatran |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with complete recanalization of thrombus in both groups.
Measured: 1 year
Secondary outcomes (15)
Number of participants with partial recanalization of thrombus in both groups.
Measured: 1 Year
Number of participants with improvements in Child-Turcotte-Pugh (CTP) in both groups.
Measured: 6 months
Number of participants with improvements in Child-Turcotte-Pugh (CTP) in both groups.
Measured: 1 year
Improvements in Model for End Stage Liver Disease (MELD) Score in both groups
MELD score ranges from 6 to 40.
Measured: 6 months
Improvements in Model for End Stage Liver Disease (MELD) Score in both groups
MELD score ranges from 6 to 40.
Measured: 1 Year
Number of participants with prevention of secondary decompensation in both groups
Measured: 1 Year
Adverse Events in both groups
Measured: 1 year
To study the changes in coagulation parameters by ROTEM(Rotational Thrombo Elastometry) analysis which includes CFT(clot formation time).
Measured: 6 Months
To study the changes in coagulation parameters by ROTEM(Rotational Thrombo Elastometry) analysis which includes CFT(clot formation time).
Measured: 12 Months
Number of participants with reduction in clinical complications in patients with PVT in both groups
Measured: 3 Months
Number of participants with reduction in clinical complications in patients with PVT in both groups
Measured: 6 Months
Number of participants with reduction in clinical complications in patients with PVT in both groups
Measured: 12 Months
To study the number of participants developing reoccurrence of PVT after treatment with Dabigatran for 12 months by Ultrasound Doppler of splenoportal venous system.
Measured: 12 months
To determine predictors for recurrence of PVT in patients with cirrhosis.
Measured: 1 year
To study the predictors of development of PVT in the population of cirrhosis patients screened who did not have PVT at the initiation of the study, for the development of new PVT over the period of the study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start20 Jun 2020
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433481
- Sponsor's protocol ID
- ILBS-Cirrhosis-30
- Status last verified
- Aug 2021
- First submitted
- 29 May 2020
- Last updated
- 25 Aug 2021
- 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 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dabigatran in Patients With Cirrhosis and Portal Vein Thrombosis-A Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04433481
- Acronym / sponsor ID
- ILBS-Cirrhosis-30
- Conditions
- Liver Cirrhosis, Portal Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 16 Jun 2020 (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.
A randomized controlled trial to study the efficacy and safety of Dabigatran in Cirrhotic patients who develop PVT.In this study the patients who meet the inclusion criteria will be randomized to either receive Dabigatran or placebo [multivitamin tablet]. Blood samples will be taken \&Imaging will be done accordingly to notice progression or recanalization of PVT.The patients are followed up every 2 months up to 18 month .Then statistical analysis will be done to find whether the Dabigatran is efficacious in cirrhotic patients for recanalization of PVT.
Detailed description
Study population -All the patients of cirrhosis of liver patients visiting to ILBS and diagnosed to have non tumor portal vein thrombosis will be enrolled in the study.
Study Design - A Placebo Controlled Double Blinded RCT In this randomized controlled trial, the patients who satisfy the below inclusion and exclusion criteria will be included and they will be randomized, according to 2 groups (in total 84patients) to receive either Placebo or dabigatran 150 mg BD for 12months. These patients will be admitted to the hospital from OPD or emergency.
Study period - 1.5 years from ethics approval Intervention The patients in Group A will receive T. Dabigatran 150 mg twice a day .The patients in Group B will receive placebo [multivitamins] Monitoring and assessment At baseline, a complete history with clinical and physical examination, a record of demographic profile, standard of care biochemical investigations would be done. All included patients will be evaluated with -
- Etiology of cirrhosis
- Upper GI endoscopy
- Haemogram (including reticulocyte count)
- Coagulogram- PT/INR,APTT,TEG
- Prothrombotic profile- protein c/protein-s/AT-III/Factor V Leiden mutation/ MTHFR C677T/PROTHROMBIN G20210A/ JAK2 V617F MUTATION / Anticardiolipin Ab.
- Liver function tests, Renal function tests
- Alpha fetoprotein/PIVKA II
- USG abdomen with Doppler study
- CECT-TP or CEMRI-TP to R/O HCC or angiography when PVT diagnosis doubtful.
- HVPG+LIVER BIOPSY[optional]
- Fibro scan
- Child-Pugh score, MELD Subsequently, patients will be assessed clinically at the baseline and post-treatment every2 months till 18 months
Statistical Analysis:
The data collected will be analyzed using SPSS ver 22 by standard statistical analysis, were numerical data will be analyzed to find mean, median scores and categorical data will be analyzed using Chi square test and continuous data will be analyzed by student T test and any association will be analyzed by the univariate and multivariate analysis, log regression analysis along with ROC curve will be used and p<0.05 will be considered significant and results will be appropriately tabulated
Adverse Effects Hemorrhage - Fatal Major - intracranial, retroperitoneal, intraocular, muscle hematoma Minor TREATMENT IN CASE OF ADVERSE EFFECTS - Withdrawal of drug
Stopping rule of study Allergic reactions to drug Severe hemorrhage DIC Progression of PVT after 6 months viral reactivation leading to ACLF, acute hepatitis (viral, drug related, autoimmune flare), sepsis with severe coagulopathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DABIGATRAN | Experimental | Drug: Dabigatran150mg BD for 12 months |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical / radiological /histologic diagnosis of cirrhosis [Childs A\&B - CTP<9]
- Partial / total portal vein thrombosis (chronic)
- Age- 18-70 years
- Valid consent
Key exclusion criteria (11 listed)
- Age > 70 years
- Presence of active infection (<2 weeks)
- Use of anticoagulant drugs in the past 10 days
- Pregnancy
- HIV positivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DabigatranT. Dabigatran 150 mg twice a day | Drug | DABIGATRAN |
| Placeboplacebo | Other | Placebo |
Primary outcome
Number of participants with complete recanalization of thrombus in both groups.
Time frame: 1 year
15 secondary outcomes
Number of participants with partial recanalization of thrombus in both groups.
Time frame: 1 Year
Number of participants with improvements in Child-Turcotte-Pugh (CTP) in both groups.
Time frame: 6 months
Number of participants with improvements in Child-Turcotte-Pugh (CTP) in both groups.
Time frame: 1 year
Improvements in Model for End Stage Liver Disease (MELD) Score in both groups
Time frame: 6 months
Improvements in Model for End Stage Liver Disease (MELD) Score in both groups
Time frame: 1 Year
Number of participants with prevention of secondary decompensation in both groups
Time frame: 1 Year
Adverse Events in both groups
Time frame: 1 year
To study the changes in coagulation parameters by ROTEM(Rotational Thrombo Elastometry) analysis which includes CFT(clot formation time).
Time frame: 6 Months
To study the changes in coagulation parameters by ROTEM(Rotational Thrombo Elastometry) analysis which includes CFT(clot formation time).
Time frame: 12 Months
Number of participants with reduction in clinical complications in patients with PVT in both groups
Time frame: 3 Months
Number of participants with reduction in clinical complications in patients with PVT in both groups
Time frame: 6 Months
Number of participants with reduction in clinical complications in patients with PVT in both groups
Time frame: 12 Months
To study the number of participants developing reoccurrence of PVT after treatment with Dabigatran for 12 months by Ultrasound Doppler of splenoportal venous system.
Time frame: 12 months
To determine predictors for recurrence of PVT in patients with cirrhosis.
Time frame: 1 year
To study the predictors of development of PVT in the population of cirrhosis patients screened who did not have PVT at the initiation of the study, for the development of new PVT over the period of the study
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dabigatran in people with Liver Cirrhosis and Portal Vein Thrombosis, 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 25 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr G. Srinivasa Reddy, MD (01146300000, srinivasareddygolamari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with complete recanalization of thrombus in both groups. (time frame: 1 year). 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 25 Aug 2021.