Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
32
Countries
1
Sites
10
Spontaneous intracerebral haemorrhage
To assess the safety and tolerability profile of Ir-CPI in ICH patients
Key facts
- Sponsor
- Bioxodes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 27 Jul 2023 → ongoing
- Decision date (initial)
- 2023-02-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Bioxodes SA
External identifiers
- EU CT number
- 2022-500491-53-00
- WHO UTN
- U1111-1274-7340
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Efficacy, Therapy, Pharmacodynamic
To assess the safety and tolerability profile of Ir-CPI in ICH patients
Secondary objectives 3
- to obtain the first efficacy estimate of Ir-CPI on evolution of PHO and haemorrhage volumes
- to evaluate the pharmacokinetics of Ir-CPI in ICH patients
- to assess the pharmacodynamics of Ir-CPI in ICH patients
Conditions and MedDRA coding
Spontaneous intracerebral haemorrhage
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10022754 | Intracerebral hemorrhage | 10029205 |
| 20.1 | LLT | 10019551 | Hemorrhage intracerebral | 10029205 |
| 21.1 | LLT | 10022751 | Intracerebral bleed | 10029205 |
| 21.1 | LLT | 10048863 | Hemorrhagic stroke | 10029205 |
| 21.1 | LLT | 10022753 | Intracerebral haemorrhage | 10029205 |
| 20.1 | LLT | 10055815 | Haemorrhage intracerebral | 10029205 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Cohort 1 Participants will be randomized 3:1 in Arm 1 (receiving Ir-CPI) and Arm 2 (control). After inclusion of 8 participants, the recruitment will be set on temporary hold to allow analysis of the first PK parameters.
Once results are evaluated and acceptable, the recruitment will re-start for the second phase of the trial.
These first 8 participants will continue to be part of the trial and be followed according to the same schedule of activities as the second phase of the trial.
|
Randomised Controlled | None | Experimental: Ir-CPI: Randomized participants in the experimental arm will receive a single intravenous dose of Ir-CPI Control : no treatment: Randomized participants in the control arm will not receive experimental treatment |
|
| 2 | Cohort 2 Participants will be randomized 3:1 to Arm 1 (receiving Ir-CPI) and Arm 2 (control).
|
Randomised Controlled | None | Experimental: Ir-CPI: Randomized participants in the experimental arm will receive a single intravenous dose of Ir-CPI Control : no treatment: Randomized participants in the control arm will not receive experimental treatment |
Regulatory references
- Scientific advice from competent authorities
- Federal Agency For Medicines And Health Products
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Male or female patients aged ≥ 18 years
- written informed consent obtained
- First-ever, spontaneous, supratentorial ICH with a volume ≥ 5 mL but ≤ 60 mL
- Glasgow Coma Scale (GCS) best motor score no less than 5
- Modified Rankin Scale (mRS) score 0-2
Exclusion criteria 12
- History of bleeding disorders
- Patients with active systemic infections
- Women of childbearing potential
- body weight > 120 kg
- severe renal impairement
- Known deficiency in FXII or haemophilia
- Infratentorial ICH
- Secondary ICH
- Planned neurosurgical hematoma evacuation or other urgent surgical intervention on intial presentation
- Planned anticoagulation reversal treatment
- Patient with IVH having a Graeb score >3 on initial presentation
- use of immunosuppressive or immune modulating therapy at admission
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 6
- Adverse event/SAE monitoring
- ECGs
- Vital signs
- Physical examinations and neurological evaluations
- Biochemistry, haematology
- coagulation (aPTT)
Secondary endpoints 3
- Change from baseline in PHO and haemorrhage volumes measured by CT scan
- Change from baseline in Ir-CPI plasma concentrations
- Change from baseline in aPTT ratio, residual FXI and FXII activities and percentages of inhibition of FXI and FXII procoagulant activities
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ixodes Ricinus Contact Phase Inhibitor
PRD7584349 · Product
- Active substance
- Ixodes Ricinus Contact Phase Inhibitor
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 22 mg/Kg milligram(s)/kilogram
- Max total dose
- 38.70 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- BIOXODES
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bioxodes
- Sponsor organisation
- Bioxodes
- Address
- Rue De La Plaine 11
- City
- Marche-En-Famenne
- Postcode
- 6900
- Country
- Belgium
Scientific contact point
- Organisation
- Bioxodes
- Contact name
- Bioxodes SA - info
Public contact point
- Organisation
- Bioxodes
- Contact name
- Bioxodes SA - info
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 32 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
UZ Brussel
Neurology, Laarbeeklaan 101, 1090, Jette
UZ Leuven
Neurology, Herestraat 49, 3000, Leuven
Algemeen Ziekenhuis Groeninge
Neurology, President Kennedylaan 4, 8500, Kortrijk
Cliniques Universitaires Saint-Luc
Neurology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
CHC MontLegia
Neurology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Universitair Ziekenhuis Gent
Neurology, Corneel Heymanslaan 10, 9000, Gent
Az St-Jan Brugge-Oostende A.V.
Neurology, Ruddershove 10, 8000, Brugge
Hopital Erasme
Neurology, Lennikse Baan 808, 1070, Anderlecht
CHU Ambroise Pare
Neurology, Boulevard President Kennedy 2, 7000, Mons
Algemeen Ziekenhuis Damiaan Oostende
Neurology, Gouwelozestraat 100, 8400, Ostend
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 |
|---|---|---|---|---|---|
| Belgium | 2023-07-27 | 2023-11-17 | 2025-03-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D-Protocol-redacted | 3.0 |
| Recruitment arrangements (for publication) | K59-L62-Recruitment arrangements_ICF procedure_BE-redacted | 2.0 |
| Recruitment arrangements (for publication) | M64-Planning_List of sites-BE | 1.1 |
| Subject information and informed consent form (for publication) | L-ICF-participant-english-redacted | 3.0 |
| Subject information and informed consent form (for publication) | L-ICF-pregnant partner-english | 2.0 |
| Subject information and informed consent form (for publication) | L-Subject Information-Appointment reminder-english | 1 |
| Subject information and informed consent form (for publication) | L-Subject Information-Emergency Card-english | 1 |
| Subject information and informed consent form (for publication) | L-Subject Information-ICF Flowchart_content file-english-redacted | 2.0 |
| Subject information and informed consent form (for publication) | L-Subject Information-Participant Journey_content file-english-redacted | 2.0 |
| Synopsis of the protocol (for publication) | D24-Protocol synopsis-dutch-redacted | 3.0 |
| Synopsis of the protocol (for publication) | D24-Protocol synopsis-english-redacted | 3.0 |
| Synopsis of the protocol (for publication) | D24-Protocol synopsis-french-redacted | 3.0 |
| Synopsis of the protocol (for publication) | D24-Protocol synopsis-german-redacted | 3.0 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-08 | Belgium | Acceptable 2023-02-03
|
2023-02-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-04-26 | Belgium | Acceptable 2023-02-03
|
2023-04-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-09-29 | Belgium | Acceptable 2023-02-03
|
2023-09-29 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-11-30 | Belgium | Acceptable 2023-02-03
|
2023-11-30 |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-11 | Belgium | Acceptable 2024-01-19
|
2024-01-19 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-20 | Belgium | Acceptable 2024-05-02
|
2024-05-03 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-08-30 | Belgium | Acceptable 2024-05-02
|
2024-08-30 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-10-31 | Belgium | Acceptable 2024-05-02
|
2024-10-31 |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-25 | Belgium | Acceptable 2025-01-10
|
2025-01-10 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-09-23 | Belgium | Acceptable 2025-01-10
|
2025-09-23 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-10-01 | Belgium | Acceptable 2025-01-10
|
2025-10-01 |