Intrahepatic Non Cirrhotic Portal HypertensionPhase 3APISNCT04007289
Apixaban for Intrahepatic Non Cirrhotic Portal Hypertension
A Phase 3 study testing Apixaban in people with Intrahepatic Non Cirrhotic Portal Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Intrahepatic non-cirrhotic portal hypertension (INCPH) is a rare disease mostly affecting adults in their forties, characterized by portal hypertension related to alterations of intrahepatic microcirculation in the absence of cirrhosis.The only therapeutic options currently available for patients with INCPH include… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intrahepatic Non Cirrhotic Portal Hypertension
- What is being tested?
- Apixaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2019to 31 Dec 2026
- Phase
- Phase 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 and ≤ 90 year old male and female patients,
- For child-bearing aged women, contraception using progestatives, or intrauterine device or mechanical contraception
- Adequate prophylaxis against variceal bleeding according to EASL (European association for the study of the liver) guidelines
- Intrahepatic non cirrhotic portal hypertension (INCPH), defined according to the recent VALDIG workshop (Feb. 2017, Ascona, Italy) as having one of the following simultaneous associations:
- absence of cirrhosis on an adequate liver biopsy, and one or more signs specific for portal hypertension
- absence of cirrhosis on an adequate liver biopsy, and one or more signs not specific for portal hypertension and one or more histological signs for INCPH
- in the absence of adequate liver biopsy, 2 reliable liver stiffness values determined using transient elastography (Fibroscan) < 10 kPa and one or more signs specific for portal hypertension
Who cannot join
- Myeloproliferative disease treated with aspirin to prevent vascular events, paroxysmal nocturnal hemoglobinuria.
- Ongoing oestroprogestative contraception
- Pregnant or breastfeeding women
- Complete thrombosis of superior mesenteric vein and/or inferior mesenteric vein
- Complete portal vein thrombosis or portal cavernoma
- Recent (<6 months) partial portal venous system thrombosis
Show all 27Show fewer
- Mandatory indication or contraindication for anticoagulation according to guidelines of the American college of chest physicians
- Concomitant treatment with any other anticoagulant agent unless when bridging from one to the other is performed
- Disease at high risk of bleeding (except for portal hypertension)
- Active clinically significant bleeding:. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
- Platelet < 40000/mm3, or prothrombin index <40% in the absence of anti-vitamin K or Factor V < 40% or Fibrinogen < 1.0g/L
- Transjugular intrahepatic portosystemic shunt (TIPSS) or surgical portosystemic shunt
- Participation in another interventional trial
- Creatinine clearance < 30 mL/min
- Hepatitis C with detectable HCV RNA at inclusion
- Positive HBs Ag, except patients with HBeAg-negative chronic HBV infection, previously termed 'inactive carriers' [characterised by the presence of serum antibodies to HBeAg (anti-HBe), undetectable or low (<2,000 IU/mL) HBV DNA levels and normal serum ALT levels] that can be included
- Alcohol intake >210 g/week for men and 140 g/week for women
- Mandatory indication to aspirin or other antiplatelet agents including P2Y12 receptor antagonists according to guidelines of the American Heart Association
- Patient who underwent liver transplantation less than 3 years before screening
- Severe hepatic impairment or significant active liver injury (serum ALT level > 5 times the upper limit of normal values)
- Life expectancy <12 months
- Specific causes of portal hypertension or specific vascular liver diseases: history of bone marrow transplantation, Budd-Chiari syndrome / hepatic venous outflow obstruction, hepatic schistosomiasis diagnosed on liver biopsy (an isolated positive serology is not an exclusion criterion), cardiac failure, Fontan surgery, Abernethy syndrome, Hereditary hemorrhagic telangiectasia, chronic cholestatic diseases, liver infiltration by tumor cells
- Concomitant use of potent inhibitors of CYP3A4 or P-gp. In case of moderate interactions with apixaban (for example, immunosuppressive treatment), the dose of CYP3A4 inhibitor will be adapted according to its plasmatic level in the study patient.
- Hypersensitivity to the active substance or to any of the excipients including lactose.
- Patients unable to give consent (under guardianship or curatorship)
- No written informed consent for participation in the study
- No coverage for medical insurance
Trial locations and contacts
1 site in 1 country.
About this study
Intrahepatic non-cirrhotic portal hypertension (INCPH) is a rare disease mostly affecting adults in their forties, characterized by portal hypertension related to alterations of intrahepatic microcirculation in the absence of cirrhosis.The only therapeutic options currently available for patients with INCPH include prophylaxis for variceal bleeding using betablockers and/or endoscopic band ligation and TIPSS (transjugular intrahepatic portosystemic shunt) or liver transplantation for severe cases.
The investigators hypothesize that anticoagulation using Apixaban in patients with INCPH might prevent occurrence or extension of portal, splenic or mesenteric veins thromboses and thus the development of chronic portal vein thrombosis and associated complications, but also avoid intrahepatic thromboses and consequently liver disease progression and variceal bleeding.
Read more
The Primary Objective is to evaluate the effect of 24 months low dosing of apixaban (2.5 mg x 2/day) versus placebo on the occurrence or the extension of portal venous system thrombosis (including splenic, mesenteric veins, portal trunk or left or right portal branches) at 24 months in patients with INCPH.
166 patients will be included in 21 centers in a prospective, national multicentric, phase III, superiority comparative randomized (1:1) double-blinded clinical trial with two parallel arms: apixaban versus placebo.
Read the detailed description
Intrahepatic non-cirrhotic portal hypertension (INCPH) is a rare disease mostly affecting adults in their forties, characterized by portal hypertension related to alterations of intrahepatic microcirculation in the absence of cirrhosis.The only therapeutic options currently available for patients with INCPH include prophylaxis for variceal bleeding using betablockers and/or endoscopic band ligation and TIPSS (transjugular intrahepatic portosystemic shunt) or liver transplantation for severe cases.
The investigators hypothesize that anticoagulation using Apixaban in patients with INCPH might prevent occurrence or extension of portal, splenic or mesenteric veins thromboses and thus the development of chronic portal vein thrombosis and associated complications, but also avoid intrahepatic thromboses and consequently liver disease progression and variceal bleeding.
The Primary Objective is to evaluate the effect of 24 months low dosing of apixaban (2.5 mg x 2/day) versus placebo on the occurrence or the extension of portal venous system thrombosis (including splenic, mesenteric veins, portal trunk or left or right portal branches) at 24 months in patients with INCPH.
The Secondary Objectives are :
- To assess the safety of apixaban on: (a) any major bleeding as defined by the ISTH (International Society on Thrombosis and Haemostasis) guidelines; (b) liver toxicity; (c) adverse events and reactions.
- To compare the effect of 24 months low dosing of apixaban (2.5 mg x 2/day) versus placebo on the following outcomes, assessed during the 24 months of treatment:
- - at least one event among: deep vein thrombosis in any location, arterial thrombosis, major bleeding, death
- - the occurrence of deep vein thrombosis in any location or arterial thrombosis
- - mortality (global, liver related, non-liver related), and mortality or liver transplantation
- - each and any event among: liver decompensation, complications of portal hypertension including portal hypertensive related gastrointestinal bleeding, liver transplantation or death;
- - portal hypertension related features (spleen size, platelet count, size of esophageal varices, portal blood flow velocity) and markers of bacterial translocation and inflammation
- - liver function
- - quality of life
- To evaluate the effect of 24 months low dosing of apixaban (2.5 mg x 2/day) versus placebo on the occurrence or the extension of portal venous system thrombosis (including splenic, mesenteric veins, portal trunk or left or right portal branches) at 24 months after randomisation in patients with INCPH according to HIV status
- To identify predictors of portal venous system thrombosis and liver related events:
- in the control group: liver and spleen stiffness; portal blood flow velocity; specific coagulation tests; markers of bacterial translocation and inflammation
- in the group receiving apixaban: plasma apixaban levels
- To assess treatment compliance
- To study the occurrence or extension of portal venous system thrombosis or occurrence of deep vein thrombosis in any location or arterial thrombosis in the 6 months after the 24-month treatment with apixaban versus placebo.
166 patients will be included in 21 centers in a prospective, national multicentric, phase III, superiority comparative randomized (1:1) double-blinded clinical trial with two parallel arms: apixaban versus placebo.
- Being tested
- Apixaban, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Administration of Apixaban ; 2 clinical examinations; blood tests, 3 liver and spleen stiffness measurements, 2 contrast enhanced echocardiographies, 1 hepatic ultrasonography, Biological samples collections to identify predictors of thrombosis and liver related events
PlaceboDrug
Administration of placebo ; 2 clinical examinations; blood tests, 3 liver and spleen stiffness measurements, 2 contrast enhanced echocardiographies, 1 hepatic ultrasonography,
| Study group | Role | What they receive |
|---|---|---|
| APIXABAN | Active comparator | Apixaban, 1 pill of 2.5 mg per os twice a day (one in the morning and one in the evening) for 24 months. Receives: Drug: Apixaban |
| PLACEBO | Placebo comparator | Placebo, 1 pill per os twice a day (one in the morning and one in the evening) for 24 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal venous system thrombosis
Occurrence or extension of portal venous system thrombosis (including splenic, mesenteric veins, portal trunk or left or right portal branches) at 24 months in patients with INCPH.
Measured: 24 months
Secondary outcomes (19)
Occurrence of side effects
Any major bleeding as defined by the International Society on Thrombosis and Haemostasis guidelines; liver toxicity; adverse events and reactions.
Measured: 24 months
Composite endpoint including thrombosis and major bleeding
Cumulative incidence of one event among: deep vein thrombosis in any location, arterial thrombosis, major bleeding, death
Measured: 24 months
Occurence of vein or arterial thrombosis
Compare the effect of 24 months low dosing of apixaban (2.5 mg x 2/day) versus placebo on one event among: deep vein thrombosis in any location, arterial thrombosis,
Measured: 24 months
Mortality or liver transplantation
cumulative incidence of death (global, liver related, non liver related) or liver transplantation
Measured: 24 months
Complications of liver disease
cumulative incidence of liver decompensation, complications of portal hypertension including portal hypertensive related gastrointestinal bleeding, liver transplantation or death;
Measured: 24 months
Portal hypertension related features
change in size of oesophageal varices
Measured: 24 months
Portal hypertension related features
platelet count
Measured: 24 months
Markers of bacterial translocation and inflammation
circulating concentrations of CRP
Measured: 24 months
Liver function
change in child pugh score
Measured: 24 months
Liver function
change in MELD score
Measured: 24 months
Measure of Quality of life
change in quality of life assessed using SF36 questionnaire
Measured: 24 months
Measure of quality life
change in quality of life assessed using CLDQ questionnaire
Measured: 24 months
occurrence or the extension of portal venous system thrombosis at 24 months after randomisation in patients with INCPH according to HIV status
Compare the effect of 24 months low dosing of apixaban (2.5 mg x 2/day) versus placebo on the occurrence or the extension of portal venous system thrombosis (including splenic, mesenteric veins, portal trunk or left or right portal branches) at 24 months after randomisation in patients with INCPH according to HIV status
Measured: 24 months
predictors of portal venous system thrombosis and liver related events
In group receiving Apixaban : plasma Apixaban levels
Measured: 24 months
predictors of portal venous system thrombosis and liver related events
in the control group : portal blood flow Velocity
Measured: 24 months
predictors of portal venous system thrombosis and liver related events
in the control group : stiffness measured using Fibroscan
Measured: 24 months
predictors of portal venous system thrombosis and liver related events
in the control group : levels of specific coagulation tets (D-dimeres)
Measured: 24 months
treatment compliance
number of compliant patient
Measured: 24 months
occurrence or extension of portal venous system thrombosis or occurrence of deep vein thrombosis in any location or arterial thrombosis in the 6 months after the 24-month treatment with apixaban versus placebo
cumulative incidence of extension of portal venous system thrombosis or deep vein thrombosis in any location or arterial thrombosis in the 6 months after the 24-month treatment with apixaban versus placebo
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start24 Jun 2019
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Non Cirrhotic Portal HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a prospective, national multicentric, phase III, superiority comparative randomized (1:1) double-blinded clinical trial with two parallel arms: apixaban versus placebo.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Emmanuel RAUTOU, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007289
- Sponsor's protocol ID
- P170916J
- Acronym
- APIS
- Status last verified
- May 2025
- First submitted
- 24 May 2019
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban for Intrahepatic Non Cirrhotic Portal Hypertension
- ClinicalTrials.gov ID
- NCT04007289
- Acronym / sponsor ID
- APIS / P170916J
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jul 2019 (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.
Intrahepatic non-cirrhotic portal hypertension (INCPH) is a rare disease mostly affecting adults in their forties, characterized by portal hypertension related to alterations of intrahepatic microcirculation in the absence of cirrhosis.The only therapeutic options currently available for patients with INCPH include prophylaxis for variceal bleeding using betablockers and/or endoscopic band ligation and TIPSS (transjugular intrahepatic portosystemic shunt) or liver transplantation for severe cases.
The investigators hypothesize that anticoagulation using Apixaban in patients with INCPH might prevent occurrence or extension of portal, splenic or mesenteric veins thromboses and thus the development of chronic portal vein thrombosis and associated complications, but also avoid intrahepatic thromboses and consequently liver disease progression and variceal bleeding.
The Primary Objective is to evaluate the effect of 24 months low dosing of apixaban (2.5 mg x 2/day) versus placebo on the occurrence or the extension of portal venous system thrombosis (including splenic, mesenteric veins, portal trunk or left or right portal branches) at 24 months in patients with INCPH.
166 patients will be included in 21 centers in a prospective, national multicentric, phase III, superiority comparative randomized (1:1) double-blinded clinical trial with two parallel arms: apixaban versus placebo.
Detailed description
Intrahepatic non-cirrhotic portal hypertension (INCPH) is a rare disease mostly affecting adults in their forties, characterized by portal hypertension related to alterations of intrahepatic microcirculation in the absence of cirrhosis.The only therapeutic options currently available for patients with INCPH include prophylaxis for variceal bleeding using betablockers and/or endoscopic band ligation and TIPSS (transjugular intrahepatic portosystemic shunt) or liver transplantation for severe cases.
The investigators hypothesize that anticoagulation using Apixaban in patients with INCPH might prevent occurrence or extension of portal, splenic or mesenteric veins thromboses and thus the development of chronic portal vein thrombosis and associated complications, but also avoid intrahepatic thromboses and consequently liver disease progression and variceal bleeding.
The Primary Objective is to evaluate the effect of 24 months low dosing of apixaban (2.5 mg x 2/day) versus placebo on the occurrence or the extension of portal venous system thrombosis (including splenic, mesenteric veins, portal trunk or left or right portal branches) at 24 months in patients with INCPH.
The Secondary Objectives are :
- To assess the safety of apixaban on: (a) any major bleeding as defined by the ISTH (International Society on Thrombosis and Haemostasis) guidelines; (b) liver toxicity; (c) adverse events and reactions.
- To compare the effect of 24 months low dosing of apixaban (2.5 mg x 2/day) versus placebo on the following outcomes, assessed during the 24 months of treatment:
- - at least one event among: deep vein thrombosis in any location, arterial thrombosis, major bleeding, death
- - the occurrence of deep vein thrombosis in any location or arterial thrombosis
- - mortality (global, liver related, non-liver related), and mortality or liver transplantation
- - each and any event among: liver decompensation, complications of portal hypertension including portal hypertensive related gastrointestinal bleeding, liver transplantation or death;
- - portal hypertension related features (spleen size, platelet count, size of esophageal varices, portal blood flow velocity) and markers of bacterial translocation and inflammation
- - liver function
- - quality of life
- To evaluate the effect of 24 months low dosing of apixaban (2.5 mg x 2/day) versus placebo on the occurrence or the extension of portal venous system thrombosis (including splenic, mesenteric veins, portal trunk or left or right portal branches) at 24 months after randomisation in patients with INCPH according to HIV status
- To identify predictors of portal venous system thrombosis and liver related events:
- in the control group: liver and spleen stiffness; portal blood flow velocity; specific coagulation tests; markers of bacterial translocation and inflammation
- in the group receiving apixaban: plasma apixaban levels
- To assess treatment compliance
- To study the occurrence or extension of portal venous system thrombosis or occurrence of deep vein thrombosis in any location or arterial thrombosis in the 6 months after the 24-month treatment with apixaban versus placebo.
166 patients will be included in 21 centers in a prospective, national multicentric, phase III, superiority comparative randomized (1:1) double-blinded clinical trial with two parallel arms: apixaban versus placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be a prospective, national multicentric, phase III, superiority comparative randomized (1:1) double-blinded clinical trial with two parallel arms: apixaban versus placebo.
| Arm | Type | Receives |
|---|---|---|
| APIXABAN | Active comparator | Drug: ApixabanApixaban, 1 pill of 2.5 mg per os twice a day (one in the morning and one in the evening) for 24 months. |
| PLACEBO | Placebo comparator | Drug: PlaceboPlacebo, 1 pill per os twice a day (one in the morning and one in the evening) for 24 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 and ≤ 90 year old male and female patients,
- For child-bearing aged women, contraception using progestatives, or intrauterine device or mechanical contraception
- Adequate prophylaxis against variceal bleeding according to EASL (European association for the study of the liver) guidelines
- Intrahepatic non cirrhotic portal hypertension (INCPH), defined according to the recent VALDIG workshop (Feb. 2017, Ascona, Italy) as having one of the following simultaneous associations:
Key exclusion criteria (27 listed)
- Myeloproliferative disease treated with aspirin to prevent vascular events, paroxysmal nocturnal hemoglobinuria.
- Ongoing oestroprogestative contraception
- Pregnant or breastfeeding women
- Complete thrombosis of superior mesenteric vein and/or inferior mesenteric vein
- Complete portal vein thrombosis or portal cavernoma
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 |
|---|---|---|
| ApixabanAdministration of Apixaban ; 2 clinical examinations; blood tests, 3 liver and spleen stiffness measurements, 2 contrast enhanced echocardiographies, 1 hepatic ultrasonography, Biological samples collections to identify predictors of thrombosis and liver related events | Drug | APIXABAN |
| PlaceboAdministration of placebo ; 2 clinical examinations; blood tests, 3 liver and spleen stiffness measurements, 2 contrast enhanced echocardiographies, 1 hepatic ultrasonography, | Drug | PLACEBO |
Primary outcome
Portal venous system thrombosis
Time frame: 24 months
Occurrence or extension of portal venous system thrombosis (including splenic, mesenteric veins, portal trunk or left or right portal branches) at 24 months in patients with INCPH.
19 secondary outcomes
Occurrence of side effects
Time frame: 24 months
Composite endpoint including thrombosis and major bleeding
Time frame: 24 months
Occurence of vein or arterial thrombosis
Time frame: 24 months
Mortality or liver transplantation
Time frame: 24 months
Complications of liver disease
Time frame: 24 months
Portal hypertension related features
Time frame: 24 months
Portal hypertension related features
Time frame: 24 months
Markers of bacterial translocation and inflammation
Time frame: 24 months
Liver function
Time frame: 24 months
Liver function
Time frame: 24 months
Measure of Quality of life
Time frame: 24 months
Measure of quality life
Time frame: 24 months
occurrence or the extension of portal venous system thrombosis at 24 months after randomisation in patients with INCPH according to HIV status
Time frame: 24 months
predictors of portal venous system thrombosis and liver related events
Time frame: 24 months
predictors of portal venous system thrombosis and liver related events
Time frame: 24 months
predictors of portal venous system thrombosis and liver related events
Time frame: 24 months
predictors of portal venous system thrombosis and liver related events
Time frame: 24 months
treatment compliance
Time frame: 24 months
occurrence or extension of portal venous system thrombosis or occurrence of deep vein thrombosis in any location or arterial thrombosis in the 6 months after the 24-month treatment with apixaban versus placebo
Time frame: 30 months
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 25 May 2025.
- Individual participant dataSharing planned: Undecided
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Freiburg TIPS Registry
Liver Cirrhosis, Portal Hypertension
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.
Pierre Emmanuel RAUTOU principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apixaban in people with Intrahepatic Non Cirrhotic Portal Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 25 May 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 France. 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.
What does this phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal venous system thrombosis (time frame: 24 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 25 May 2025.