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Набор скоро начнётся NCT07435922

Evaluate Recombinant Human Serum Albumin From Oryza Sativa In Patients With Hypoalbuminemia and/or Hypovolemia Requiring Urgent Treatment

— Наблюдательное Hypoalbuminemia Hypovolemia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Recombinant Human Serum Albumin From Oryza Sativa.
Кому может быть актуально
Состояния в реестре: Hypoalbuminemia, Hypovolemia. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Recombinant Human Serum Albumin From Oryza Sativa In Patients With Hypoalbuminemia and/or Hypovolemia Requiring Urgent Treatment: A ReaL World Observational Study

Обзор

This study is a post-marketing, multicenter, prospective, open-label observational study. It plans to enroll approximately 2,000 patients with hypoalbuminemia and/or hypovolemia requiring urgent treatment who are scheduled to receive at least one dose of Recombinant Human Albumin from Oryza Sativa. The study does not interfere with clinical diagnosis and treatment; the use of the study drug is solely determined by the attending physician based on the patient's condition and clinical guidelines. Study data will be collected during the patient's participation in the study, including baseline characteristics, medical history, concomitant medications, records of study drug administration and reasons for use, serum albumin levels (baseline and end of treatment), adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), and adverse events of special interest (AESIs). The follow-up period will primarily be conducted via telephone. The primary endpoint of the study is the incidence of all adverse drug reactions (ADRs). Secondary endpoints include the incidence of all adverse events (AEs), the incidence of AEs by severity, the incidence of serious adverse events (SAEs), the incidence of adverse events of special interest (AESIs), and the incidence of AEs leading to dose interruption, dose reduction, discontinuation, or death related to Recombinant Human Albumin Injection from Oryza Sativa. Efficacy evaluations include changes in serum albumin concentration before and after treatment and assessment of volume restoration.

Вмешательства

  • Препарат Recombinant Human Serum Albumin From Oryza Sativa
    The treatment of the study drug will be solely determined by the attending physician based on the patient's condition and clinical guidelines.

Первичные конечные точки

  • incidence of all adverse drug reactions [Срок оценки: During treatment to a month after treatment]
Вторичные конечные точки (5)
  • The incidence of all adverse events (AEs) [Срок оценки: During treatment to a month after treatment]
  • The incidence of serious adverse events. [Срок оценки: During treatment to a month after treatment]
  • The incidence of adverse events of special interest (AESIs). [Срок оценки: During treatment to a month after treatment]
  • The incidence of AEs leading to dose interruption, dose reduction, discontinuation, or death related to Recombinant Human Albumin Injection from Oryza Sativa. [Срок оценки: During treatment to a month after treatment]
  • Changes from baseline in serum albumin concentration. [Срок оценки: One day after the end of treatment]

Критерии участия

Критерии включения

  • Age ≥ 18 years, male or female.
  • Hypoalbuminemia and/or hypovolemia requiring urgent treatment.
  • Agree to participate in this study and sign a written informed consent form by the subject themselves or their legal representative (guardian).
  • In real-world clinical practice, the attending physician has decided and planned to administer at least one dose of human albumin injection.

Критерии исключения

  • Known allergy to the active ingredients or any excipients of this product.
  • Any medical condition that, in the investigator's judgment, may significantly increase the subject's risk or interfere with their participation in and completion of this study.
  • Participation in any other clinical trial of a drug at the time of enrollment in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Hebei medical university third hosipital — Shijiazhuang

Идентификаторы

NCT: NCT07435922 · HY1001-2025-P4

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗