Evaluate Recombinant Human Serum Albumin From Oryza Sativa In Patients With Hypoalbuminemia and/or Hypovolemia Requiring Urgent Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Recombinant Human Serum Albumin From Oryza Sativa.
- Who it may be relevant to
- Registry conditions: Hypoalbuminemia, Hypovolemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Recombinant Human Serum Albumin From Oryza Sativa In Patients With Hypoalbuminemia and/or Hypovolemia Requiring Urgent Treatment: A ReaL World Observational Study
Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- incidence of all adverse drug reactions [Time frame: During treatment to a month after treatment]
Secondary outcome measures (5)
- The incidence of all adverse events (AEs) [Time frame: During treatment to a month after treatment]
- The incidence of serious adverse events. [Time frame: During treatment to a month after treatment]
- The incidence of adverse events of special interest (AESIs). [Time frame: 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. [Time frame: During treatment to a month after treatment]
- Changes from baseline in serum albumin concentration. [Time frame: One day after the end of treatment]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Hebei medical university third hosipital — Shijiazhuang
Identifiers
NCT: NCT07435922 · HY1001-2025-P4