Clinical trial • Phase II • Cardiology|Neurology

HUMAN ALBUMIN SOLUTION for Ischemic stroke

Phase II trial of HUMAN ALBUMIN SOLUTION for Ischemic stroke.

Overview

Trial Therapeutic Area
Cardiology|Neurology
Trial Disease
Ischemic stroke
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme|Small molecule

Key dates

Initial CTIS Submission Date
03-01-2025
First CTIS Authorization Date
26-03-2025

Trial design

Comparator arms: Test: HUMAN ALBUMIN SOLUTION (infusion). Placebo: Sodium chloride Fresenius Kabi 0.9% infusion (placebo). Both products listed with maximum total dose 100 ml; specific dosing schedule not specified in available record.-controlled Phase II trial in Czechia.

Comparator
Comparator arms: Test: HUMAN ALBUMIN SOLUTION (infusion). Placebo: Sodium chloride Fresenius Kabi 0.9% infusion (placebo). Both products listed with maximum total dose 100 ml; specific dosing schedule not specified in available record.
Target Sample Size
100
Trial Duration For Participant
90

Eligibility

Recruits 100 Provision of consent to participate in the clinical study by the patient or an independent physician, depending on the patient’s medical condition. Vulnerable population not selected in trial metadata..

Pregnancy Exclusion
Pregnancy or breastfeeding.
Vulnerable Population
Provision of consent to participate in the clinical study by the patient or an independent physician, depending on the patient’s medical condition. Vulnerable population not selected in trial metadata.

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years."}
  • {"criterion_text":"- Provision of consent to participate in the clinical study by the patient or an independent physician, depending on the patient’s medical condition."}
  • {"criterion_text":"- Diagnosis of ischemic stroke (iCMP) in the anterior circulation, with or without thrombolysis"}
  • {"criterion_text":"- Indication for a vasographic intervention – mechanical recanalization at a stroke center"}
  • {"criterion_text":"- 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

  • {"criterion_text":"- Known hypersensitivity to albumin preparations or their excipients."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- 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/)."}
  • {"criterion_text":"- Hypernatremia > 150 mmol/L."}
  • {"criterion_text":"- Participation in another clinical trial involving an investigational medicinal product within 30 days prior to screening."}
  • {"criterion_text":"- Pregnancy or breastfeeding."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Concentration of syndecan-1 in blood serum","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Concentration of GAG in urine.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Mortality of enrolled patients on Day 90","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Size of the ischemic brain lesion in patients with iCMP after low-dose albumin administration on control CT (MRI in exceptional cases).","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Modified Rankin Scale (mRS) scores before the onset of iCMP and on Day 90.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Neurological examination scores at screening and on Day 7/before discharge/transfer from the hospital","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
100
Recruitment Window Months
24
Consent Approach
Provision of consent to participate in the clinical study by the patient or an independent physician, depending on the patient’s medical condition. Subject information and informed consent form documents are listed in the trial documentation.

Geography

Total Number Of Sites
1
Total Number Of Participants
100

Czechia

Earliest CTIS Part Ii Submission Date
06-03-2025
Latest Decision Or Authorization Date
26-03-2025
Processing Time Days
20
Number Of Sites
1
Number Of Participants
100

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Neurologická klinika
Contact Person Name
Eva Vítková
Contact Person Email
eva.vitkova@fnhk.cz
Number Of Participants
100

Sponsor

Primary sponsor

Full Name
Fakultni Nemocnice Hradec Kralove
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Czechia

Investigational products

Investigational Product Name
HUMAN ALBUMIN SOLUTION
Active Substance
HUMAN ALBUMIN SOLUTION
Modality
Peptide/protein/enzyme
Routes Of Administration
Infusion
Route
Infusion
Maximum Dose
100 ml
Investigational Product Name
Sodium chloride Fresenius Kabi 0,9% infuzní roztok
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
Infusion
Route
Infusion
Maximum Dose
100 ml

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