Overview
Sponsor-declared trial summary
short bowel syndrome
The main aim of this study is to assess the clinical outcomes of this patient population treated with long-term parenteral nutrition and taking rivaroxaban and to relate these clinical outcomes to the laboratory assessments. The primary outcomes are the clinical outcomes after at least one year an the (varibaility in t…
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 22 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519078-38-00
- EudraCT number
- 2018-001845-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The main aim of this study is to assess the clinical outcomes of this patient population treated with long-term parenteral nutrition and taking rivaroxaban and to relate these clinical outcomes to the laboratory assessments. The primary outcomes are the clinical outcomes after at least one year an the (varibaility in the) laboratory concentrations
Secondary objectives 1
- Secondary outcomes consist assessment of the quality of life in this patient population
Conditions and MedDRA coding
short bowel syndrome
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- diagnosis of short bowel syndrome (<170cm after Treitz ligamentum) or intestinal malabsorption, diagnosed by an endocrinologist in the AMC
- Current use of Total Parenteral Nutrition
- Age 18 years or over
- Indication for anticogulant therapy before the start of TPN (DOAC, vit K antagonist, heparin) such as stroke prevention in patient with atrial fibrillation, prevention of venous thromboembolic events
Exclusion criteria 6
- Systomatic thrombosis at inclusion
- Major bleeding defined according to the ISTH in the 6mnths prior to start particiupation
- Contraindication for direct oral anticoagulant
- Gastrectomy or short-bowel syndrome <30cm after Treitz ligamentum
- Medical of psychological condition that would not permit completion of the study or signing of informed consent
- Non-compliance or inability to adhere treatment or to the follow-up visits
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- i. Main study parameter/endpoint Clinical outcomes after one year, related to the laboratory levels per subject: * Efficacy: venous thromboembolism, cerebrovascular stroke * Safety: (major) bleeding cfr. ISTH criteria, mortality ii. Secondary study parameters/endpoints * Inter- and intraindividual variability of rivaroxaban absorption Laboratory outcomes: * Correlation between anti Xa levels and rivaroxaban plasma concetrations as assessed by LC-MS/MS Quality of life assessment * SF-36
Secondary endpoints 1
- iii. Other study parameters Baseline characteristics will be collected; * Age * Sex
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Xarelto 20 mg film-coated tablets
PRD2976469 · Product
- Active substance
- Rivaroxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF01 — -
- Marketing authorisation
- EU/1/08/472/037
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Thijs van Haaps
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Thijs van Haaps
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruiting | 24 | 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 |
|---|---|---|---|---|---|
| Netherlands | 2024-11-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | C1_protocol_NL6386301818 | 4 |
| Recruitment arrangements (for publication) | Blank document TINCRBEL | 1 |
| Subject information and informed consent form (for publication) | E1 + E2 patienteninfo en toestemming voor dossier NL6386301818 | 7 |
| Summary of Product Characteristics (SmPC) (for publication) | D2_SPC_rivaroxaban20mg | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-15 | Netherlands | Acceptable 2024-11-22
|
2024-11-22 |