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2023-509261-20-00RecruitingPhase 2

Modulation of the Extent of Ischemic Brain Damage by Protecting the Endothelial Glycocalyx with Low-Dose Albumin Administration (MOZEG)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

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Brief summary (registry, in English)

Evaluation of the efficacy of albumin as a protection for the glycocalyx and endothelial functions.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
100 (estimated)
First submitted
3 Jan 2025
Start date
9 Feb 2026
Lead sponsor
Fakultni Nemocnice Hradec Kralove
Diseases
Stroke
EU CT number
2023-509261-20-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 100
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in another clinical trial involving an investigational medicinal product within 30 days prior to screening.

Other illness

  • 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/).

Lab values

  • Known hypersensitivity to albumin preparations or their excipients.
  • Hypernatremia > 150 mmol/L.

Other

  • Pregnancy or breastfeeding.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fakultni nemocnice Hradec KraloveHradec KrálovéCzechiaRecruiting

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