Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
56
Countries
1
Sites
1
Porto-Sinusoidal Vascular Disorder
To assess the safety and tolerability of edoxaban treatment in patients with PSVD
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 4 Apr 2025 → ongoing
- Decision date (initial)
- 2025-01-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Ludwig Boltzmann Society
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy
To assess the safety and tolerability of edoxaban treatment in patients with PSVD
Secondary objectives 4
- To assess the preliminary efficacy of edoxaban treatment for the prevention of splanchnic vein thrombosis (SVT) development.
- To assess the effects of edoxaban treatment on spleen stiffness as a surrogate of portal hypertension severity measured before and after edoxaban treatment.
- To assess the preliminary efficacy of edoxaban treatment for the prevention of hepatic decompensation.
- To assess effects of edoxaban treatment on health-related quality of life.
Conditions and MedDRA coding
Porto-Sinusoidal Vascular Disorder
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult patients (≥18 years) with histologically confirmed diagnosis of PSVD
- Preserved or mildly impaired liver function (corresponding to Child-Pugh-Stage A or B)
- Willing to provide written informed consent and participate in the study
- Effective bleeding prophylaxis if indicated
Exclusion criteria 10
- Any previous or current thrombosis in the spleno-portal axis
- Current indication for therapeutic anticoagulation (e.g., atrial fibrillation, deep vein thrombosis, pulmonary embolism, etc.). Note: Patients with an indication for prophylactic anticoagulation will be allowed for this study
- Active bleeding, clinically significant risk of major bleeding or any other contraindication for anticoagulant treatment
- Pregnancy or lactation
- Ascites needing large-volume paracentesis
- Patients in need for repeated interventions (not including variceal band ligation)
- Any comorbidity resulting in a life expectancy <24 months
- Severe thrombocytopenia (platelets <40 G/L)
- Kidney failure (creatinine clearance <15mL / min)
- Transjugular intrahepatic portosystemic shunt or portosystemic shunt carrier
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of major bleedings (will be defined according to the International Society on Thrombosis and Haemostasis [ISTH])
Secondary endpoints 4
- To assess the preliminary efficacy of edoxaban treatment for the prevention of splanchnic vein thrombosis (SVT) development
- To assess the effects of edoxaban treatment on spleen stiffness as a surrogate of portal hypertension severity measured before and after edoxaban treatment.
- To assess the preliminary efficacy of edoxaban treatment for the prevention of hepatic decompensation.
- To assess effects of edoxaban treatment on health-related quality of life.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Lixiana 60 mg film-coated tablets
PRD2965685 · Product
- Active substance
- Edoxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AF03 — -
- Marketing authorisation
- EU/1/15/993/003
- MA holder
- DAIICHI SANKYO EUROPE GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- over-encapsulated for blinding
Lixiana 30 mg film-coated tablets
PRD2965666 · Product
- Active substance
- Edoxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AF03 — -
- Marketing authorisation
- EU/1/15/993/002
- MA holder
- DAIICHI SANKYO EUROPE GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- over-encapsulated for blinding
Placebo 1
Placebo consists of gelatine capsules filled with maltodextrin
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Medicine III
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Medicine III
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 56 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-04-04 | 2025-04-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513353-73-00_redacted | 1.1 |
| Protocol (for publication) | D4_Patient facing document_DE_CLDQ | na |
| Protocol (for publication) | D4_Patient facing document_DE_FSS | 1 |
| Protocol (for publication) | D4_Patient facing document_DE_SF36v2 | na |
| Protocol (for publication) | eCRF_draft_2024-513353-73-00 | na |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_redacted | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_EN_Lixiana | na |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_2024-513353-73-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2024-513353-73-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-24 | Austria | Acceptable 2025-01-27
|
2025-01-31 |