Overview
Sponsor-declared trial summary
Traumatic Brain Injury
To study the safety and efficacy of C1-INH in patients with traumatic brain injury
Key facts
- Sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 9 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514488-24-02
- EudraCT number
- 2020-000140-58
- ClinicalTrials.gov
- NCT04489160
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To study the safety and efficacy of C1-INH in patients with traumatic brain injury
Conditions and MedDRA coding
Traumatic Brain Injury
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514488-24-01 | (CIAO@TBI) Complement Inhibition: Attacking Overshooting Inflammation @fter traumatic brain injury | Leids Universitair Medisch Centrum (LUMC) |
| 2024-514488-24-00 | (CIAO@TBI) Complement Inhibition: Attacking Overshooting Inflammation @fter traumatic brain injury | Leids Universitair Medisch Centrum (LUMC) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Traumatic Brain Injury
- Age > 18 years
- GCS < 13
- ICP monitor
Exclusion criteria 1
- < 18 years
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Therapy Intensity Level Scale
Secondary endpoints 2
- Serious Adverse Events (SAE)
- Glasgow Outcome Scale Extended
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cinryze 500 IU powder and solvent for solution for injection
PRD3536225 · Product
- Active substance
- C1 Esterase Inhibitor (Human)
- Substance synonyms
- C1 INHIBITOR (HUMAN), Human C1-esterase inhibitor, C1-ESTERASE INHIBITOR, HUMAN
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 6000 IU international unit(s)
- Max total dose
- 6000 IU international unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B06AC01 — -
- Marketing authorisation
- EU/1/11/688/001
- MA holder
- TAKEDA MANUFACTURING AUSTRIA AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- other indication
Placebo 1
Saline Solution Basi 9 mg/ml solution for infusion
PRD11121726 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 6000 IU international unit(s)
- Max total dose
- 6000 IU international unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 5211800
- MA holder
- LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A.
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leids Universitair Medisch Centrum (LUMC)
- Sponsor organisation
- Leids Universitair Medisch Centrum (LUMC)
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Inge van Erp
Public contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Inge van Erp
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruiting | 106 | 3 |
| 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 | 2024-10-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1. Protocol 2024-514488-24-00 | 8 |
| Recruitment arrangements (for publication) | K1_Template_recruitment_procedure_NL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF follow-up | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2. SmPC Cinryze | 1 |
| Synopsis of the protocol (for publication) | D1_Template_Protocol_synopsis_Dutch | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-12 | Netherlands | Acceptable with conditions 2024-10-08
|
2024-10-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-09 | Netherlands | Acceptable 2026-01-23
|
2026-01-23 |