Hypoalbuminemia, Hypovolemia
Conditions
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.
Interventions
DRUGRecombinant 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.
Sponsors
Healthgen Biotechnology Corp.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of all adverse drug reactions | During treatment to a month after treatment |
Secondary
| 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 |
Countries
China
Contacts
CONTACTYuemin Lan, MD
Outcome results
None listed