Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
1
Ischemic stroke
Evaluation of the efficacy of albumin as a protection for the glycocalyx and endothelial functions.
Key facts
- Sponsor
- Fakultni Nemocnice Hradec Kralove
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 9 Feb 2026 → ongoing
- Decision date (initial)
- 2025-03-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- University hospital Hradec Králové
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Evaluation of the efficacy of albumin as a protection for the glycocalyx and endothelial functions.
Secondary objectives 5
- Monitoring the safety of low-dose albumin administration as protection for the endothelial glycocalyx in patients with ischemic stroke (iCMP).
- Assessment of mortality in enrolled patients on Day 90.
- Monitoring the size of the ischemic brain lesion in patients with iCMP after low-dose albumin administration on control CT (MRI in exceptional cases).
- Comparison of the modified Rankin Scale (mRS) before the onset of iCMP and before discharge/transfer from the Hospital.
- Comparison of the results of the initial neurological examination with the examination before discharge/transfer from the hospital
Conditions and MedDRA coding
Ischemic stroke
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | LLT | 10055221 | Ischemic stroke | 10029205 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age ≥ 18 years.
- Provision of consent to participate in the clinical study by the patient or an independent physician, depending on the patient’s medical condition.
- Diagnosis of ischemic stroke (iCMP) in the anterior circulation, with or without thrombolysis
- Indication for a vasographic intervention – mechanical recanalization at a stroke center
- For women of childbearing potential: Willingness to use highly effective methods of contraception throughout the clinical trial and until Day 21 (inclusive) after administration of the investigational medicinal product. Given the medical condition of the enrolled patients, complete sexual abstinence appears to be the most appropriate option.
Exclusion criteria 6
- Known hypersensitivity to albumin preparations or their excipients.
- Signs of hypervolemia and hyperhydration or risk of their development (e.g., symptoms of acute heart failure or decompensated chronic heart failure, such as anasarca or pulmonary edema).
- Signs of other conditions listed as contraindications in the SmPC for Alburex (e.g., bleeding from esophageal varices or other life-threatening hemorrhage associated with anemia, renal failure /renal or post-renal/).
- Hypernatremia > 150 mmol/L.
- Participation in another clinical trial involving an investigational medicinal product within 30 days prior to screening.
- Pregnancy or breastfeeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Concentration of syndecan-1 in blood serum
- Concentration of GAG in urine.
Secondary endpoints 4
- Mortality of enrolled patients on Day 90
- Size of the ischemic brain lesion in patients with iCMP after low-dose albumin administration on control CT (MRI in exceptional cases).
- Modified Rankin Scale (mRS) scores before the onset of iCMP and on Day 90.
- Neurological examination scores at screening and on Day 7/before discharge/transfer from the hospital
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB12026MIG · Substance
- Active substance
- Human Albumin Solution
- Pharmaceutical form
- INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 100 ml millilitre(s)
- Max total dose
- 100 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Sodium chloride Fresenius Kabi 0,9% infuzní roztok
PRD2128237 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 100 ml millilitre(s)
- Max total dose
- 100 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 76/365/96-C
- MA holder
- FRESENIUS KABI S.R.O.
- MA country
- Czech Republic
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fakultni Nemocnice Hradec Kralove
- Sponsor organisation
- Fakultni Nemocnice Hradec Kralove
- Address
- Sokolska 581
- City
- Novy Hradec Kralove
- Postcode
- 500 03
- Country
- Czechia
Scientific contact point
- Organisation
- Fakultni Nemocnice Hradec Kralove
- Contact name
- Astapenko David, doc.MUDr., Ph.D., MBA
Public contact point
- Organisation
- Fakultni Nemocnice Hradec Kralove
- Contact name
- Krempová Johana, Mgr.
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Fakultni Nemocnice Hradec Kralove
Neurologická klinika, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
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 |
|---|---|---|---|---|---|
| Czechia | 2026-02-09 | 2026-02-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | MOZEG_Protokol | 1.1 |
| Recruitment arrangements (for publication) | MOZEG_sablona 1_nabor | 1 |
| Subject information and informed consent form (for publication) | MOZEG Souhlas nezavisleho lekare_verze 1_02DEC2024 | 1 |
| Subject information and informed consent form (for publication) | MOZEG_Informace pro pacienty a IS s pokracovanim_verze 1_02JAN2025 | 1 |
| Subject information and informed consent form (for publication) | MOZEG_Zkracene informace pro pacienty a IS_verze 1_02JAN2025 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Alburex_SmPC_2020 | 1 |
| Synopsis of the protocol (for publication) | MOZEG Synopse k protokolu | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-03 | Czechia | Acceptable 2025-03-25
|
2025-03-26 |