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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• incidence of all adverse drug reactions — During treatment to a month after treatment

Trial sites (1)

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