CirrhosisPhase 4NCT07132515
Efficacy & Safety of Anticoagulants in Cirrhosis ± HCC
A Phase 4 study testing Enoxaparin, warfarrin, or apixaban in people with Cirrhosis and HCC - Hepatocellular Carcinoma, run by Mansoura University at 1 site in Egypt.
Trial summary
We will give an anticoagulant against portal vein thrombosis, and watch for the results. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis, HCC - Hepatocellular Carcinoma, Portal Vein Thrombosis
- What is being tested?
- Enoxaparin, warfarrin, or apixaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2023to Aug 2025
- Phase
- Phase 4
- 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
- Portal vein thrombosis, Cirrhosis, With or without HCC, Child A \& B
Who cannot join
- Platelets<10000, Createnine >1.9, Budd ciarri, Uncontrolled active bleeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
Dalia E Tawfik, +20 1095529264, dalia.tawfik97@gmail.com
About this study
Official title: Efficacy and Safety of Anticoagulant Therapy for Portal Vein Thrombosis In Cirrhosis Patients With and Without Hepatocellular Carcinoma
We will give an anticoagulant against portal vein thrombosis, and watch for the results.
- Being tested
- Enoxaparin, warfarrin, or apixaban
- Medical subject headings
- Fibrosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin, warfarrin, or apixabanDrug
Enoxaparin, warfarrin, or apixaban
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulant in cirrhosis with HCC | Experimental | HCC patient on anticogulant like Enoxaparin (clexan), warfarrin(marivan), or DOAC(apixaban) Receives: Drug: Enoxaparin, warfarrin, or apixaban |
| Anticoagulant in Cirrhosis without HCC | Experimental | Benign thrombus in cirrhotic patient on anticoagulant like Enoxaparin (clexan), warfarrin(marivan), or DOAC(apixaban) Receives: Drug: Enoxaparin, warfarrin, or apixaban |
| No anticoagualnt in Cirrhosis with or without HCC | No intervention | cirrhotic patients with thrombosis with or without HCC not on anticoagulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal vein thrombosis
determine if thrombus resolved or not on anticcoagulant by triphasic CT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start15 Aug 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132515
- Sponsor's protocol ID
- MS.23.07.2479
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: when this clinical trial will be finished and have the results
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Anticoagulant Therapy for Portal Vein Thrombosis In Cirrhosis Patients With and Without Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07132515
- Acronym / sponsor ID
- MS.23.07.2479
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 20 Aug 2025 (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.
We will give an anticoagulant against portal vein thrombosis, and watch for the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anticoagulant in cirrhosis with HCC | Experimental | Drug: Enoxaparin, warfarrin, or apixabanHCC patient on anticogulant like Enoxaparin (clexan), warfarrin(marivan), or DOAC(apixaban) |
| Anticoagulant in Cirrhosis without HCC | Experimental | Drug: Enoxaparin, warfarrin, or apixabanBenign thrombus in cirrhotic patient on anticoagulant like Enoxaparin (clexan), warfarrin(marivan), or DOAC(apixaban) |
| No anticoagualnt in Cirrhosis with or without HCC | No intervention | –cirrhotic patients with thrombosis with or without HCC not on anticoagulant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Portal vein thrombosis, Cirrhosis, With or without HCC, Child A \& B
Key exclusion criteria (1 listed)
- Platelets<10000, Createnine >1.9, Budd ciarri, Uncontrolled active bleeding
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 |
|---|---|---|
| Enoxaparin, warfarrin, or apixabanEnoxaparin, warfarrin, or apixaban | Drug | Anticoagulant in Cirrhosis without HCC, Anticoagulant in cirrhosis with HCC |
Primary outcome
Portal vein thrombosis
Time frame: 6 months
determine if thrombus resolved or not on anticcoagulant by triphasic CT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Yes. when this clinical trial will be finished and have the results
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin, warfarrin, or apixaban in people with Cirrhosis and HCC - Hepatocellular Carcinoma, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Aug 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 Egypt. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Dalia Elsayed Ganady, MBBS (+201095529264, dalia.tawfik97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal vein thrombosis (time frame: 6 months). 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 20 Aug 2025.