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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypovolemia; Hypoalbuminemia
• Intervention / Treatment: Drug: Recombinant Human Serum Albumin From Oryza Sativa

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Yuemin Lan, MD; Phone Number: +86-185 3311 2266; Email: nanyuemin@163.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China
      • Hebei medical university third hosipital
      • Contact: Yuemin Lan, MD; Phone Number: +86-185 3311 2266; Email: nanyuemin@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients With Hypoalbuminemia and/or Hypovolemia Requiring Urgent Treatment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Recombinant Human Serum Albumin From Oryza Sativa	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of all adverse drug reactions	During treatment to a month after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of all adverse events (AEs)	During treatment to a month after treatment
The incidence of serious adverse events.	During treatment to a month after treatment
The incidence of adverse events of special interest (AESIs).	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.	During treatment to a month after treatment
Changes from baseline in serum albumin concentration.	One day after the end of treatment

Collaborators and Investigators

• Sponsor: Healthgen Biotechnology Corp.

Study record dates

Study Major Dates

• Study Start (Estimated): February 24, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 21, 2026
• First Submitted That Met QC Criteria: February 21, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Blood Protein Disorders; Hypoproteinemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Hypovolemia; Hypoalbuminemia
• Other Study ID Numbers: HY1001-2025-P4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No