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Portal Vein ThrombosisPhase 2/3NCT06818279

Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis

A Phase 2/3 study testing Dabigatran and Enoxaparin in people with Portal Vein Thrombosis and Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Portal vein thrombosis (PVT) is prevalent among patients with cirrhosis, and its prevalence rises with the severity of liver disease. Numerous studies have indicated that patients developing PVT experience elevated portal pressure and associated complications, such as increased incidence of variceal bleeding, higher… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Portal Vein Thrombosis, Liver Cirrhosis
What is being tested?
Dabigatran and Enoxaparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteIndia
Study dates
31 Jan 2025to 31 Jan 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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

  • Age >18 years
  • Cirrhosis with portal vein thrombosis within 6 months of diagnosis/Symptomatic PVT/PVT in potential transplant recipient.

Who cannot join

  • Contraindications to anticoagulant therapy, such as active bleeding, recent major surgery, or known hypersensitivity to study medications.
  • CTP >10
  • Hepatocellular carcinoma
  • Tumoral PVT
  • Isolated gastric varices with red colour signs
  • Peptic ulcer disease with large ulcers
Show all 10Show fewer
  • Pregnant or breastfeeding women
  • Thrombocytopenia (platelet count <50,000/μL)
  • Patients with concurrent acute kidney injury or chronic kidney disease stage 4 or 5
  • Those not giving consent for therapy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr Sarthak Chanana, MD contact

01146300000

xs2sarthak@gmail.com

Dr Rajan V, DM contact

01146300000

rajanvf40@gmail.com

India1 site

  • Institute of Liver & Biliary Sciences (ILBS)

    New Delhi, National Capital Territory of Delhi, 110070

    Dr Sarthak Chanana, MD, 01146300000, xs2sarthak@gmail.com

Other trials in India

About this study

Official title: Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis: A Randomized Controlled Study

Portal vein thrombosis (PVT) is prevalent among patients with cirrhosis, and its prevalence rises with the severity of liver disease. Numerous studies have indicated that patients developing PVT experience elevated portal pressure and associated complications, such as increased incidence of variceal bleeding, higher rates of failed variceal bleed control, rebleeding, and short-term mortality. Additionally, the development of PVT adversely affects post-transplant outcomes, correlating with increased 30-day mortality among transplant recipients with PVT. Current guidelines lack clarity regarding the optimal choice of anticoagulation therapy for patients with cirrhosis. This study aims to evaluate the efficacy and safety of enoxaparin and dabigatran in achieving complete recanalization of portal vein thrombosis in cirrhotic patients over a 6-month period.

Read the detailed description

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) <!-- -->
  13. Complete history and physical examination
  14. Pattern and number of decompensation
  15. MELD, CTP, APRI, ALBI Score
  16. Hemogram, Kidney function test, Liver function test, INR
  17. Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen
Being tested
Dabigatran, Enoxaparin
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 BD fixed dose to be given for duration of 6 months.

  • EnoxaparinDrug

    Enoxaparin . Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months.

Study groups in NCT06818279
Study groupRoleWhat they receive
EnoxaparinActive comparatorEnoxaparin Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months.
Receives: Drug: Enoxaparin
DabigatranExperimentalDabigatran 150 mg BD fixed dose to be given for duration of 6 months.
Receives: Drug: Dabigatran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups.

    Measured: 6 months

Secondary outcomes (11)

  1. Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups.

    Measured: 6 months

  2. Rate of partial recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups.

    Measured: 6 months

  3. Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groups.

    Measured: 3 months

  4. Rate of recurrence of Portal Vein Thrombosis at 12 months.

    Measured: 12 months

  5. Adverse events in both the groups till 6-months

    Measured: 6 months

  6. Change in CTP scores in both the groups over 12-months

    Measured: 12-months

  7. Change in MELD scores in both the groups over 12-months

    Measured: 12-months

  8. Variceal and non-variceal bleeding rates at 6-months and 12-months

    Measured: 6-months and 12-months

  9. Number of patients with worsening of decompensation events and new onset decompensation events in the two study groups till 12-months

    Decompensation events includes any of the one ascites,HE,bleed and jaundice

    Measured: 12-months

  10. Baseline parameters for predicting recanalisation of Portal Vein Thrombosis (PVT) at 6 months in both the groups.

    Measured: 12 months

  11. Baseline parameters for predicting rethrombosis of PVT at 12 months in both the groups.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start31 Jan 2025 (estimated)
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06818279
Sponsor's protocol ID
ILBS-Cirrhosis-72
Status last verified
Jan 2025
First submitted
27 Jan 2025
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dabigatran and Enoxaparin in people with Portal Vein Thrombosis and Liver Cirrhosis, 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 2 inclusion and 10 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: opening soon, as of the sponsor's last update on 10 Feb 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr Sarthak Chanana, MD (01146300000, xs2sarthak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06818279.

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 10 Feb 2025.

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