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

NCT07435922 | Not Yet Recruiting

• 1 other identifier: HY1001-2025-P4
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypovolemia; Hypoalbuminemia

Outcome Measures

Primary Outcomes (1)

• incidence of all adverse drug reactions

  During treatment to a month after treatment

Secondary Outcomes (5)

• 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

Study Arms (1)

Recombinant Human Serum Albumin From Oryza Sativa

Drug: Recombinant Human Serum Albumin From Oryza Sativa

Interventions

Recombinant Human Serum Albumin From Oryza Sativa DRUG

The treatment of the study drug will be solely determined by the attending physician based on the patient's condition and clinical guidelines.

Recombinant Human Serum Albumin From Oryza Sativa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients With Hypoalbuminemia and/or Hypovolemia Requiring Urgent Treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healthgen Biotechnology Corp.: lead

Study Sites (1)

Hebei medical university third hosipital

Shijiazhuang, Hebei, China

Location

MeSH Terms

Conditions

Hypoalbuminemia; Hypovolemia

Condition Hierarchy (Ancestors)

Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yuemin Lan, MD

CONTACT

+86-185 3311 2266; nanyuemin@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: February 27, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

CN (1)