HypoalbuminemiaNCT07435922
Evaluate Recombinant Human Serum Albumin From Oryza Sativa In Patients With Hypoalbuminemia and/or Hypovolemia Requiring Urgent Treatment
An observational study of Hypoalbuminemia and Hypovolemia, run by Healthgen Biotechnology Corp. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoalbuminemia, Hypovolemia
- What is being tested?
- Recombinant Human Serum Albumin From Oryza Sativa
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients With Hypoalbuminemia and/or Hypovolemia Requiring Urgent Treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Hebei medical university third hosipital
Shijiazhuang, Hebei
Yuemin Lan, MD, +86-185 3311 2266, nanyuemin@163.com
About this study
Official title: 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.
- Conditions
- Hypoalbuminemia, Hypovolemia
- Being tested
- Recombinant Human Serum Albumin From Oryza Sativa
- Medical subject headings
- Hypoalbuminemia, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Serum Albumin From Oryza SativaDrug
The treatment of the study drug will be solely determined by the attending physician based on the patient's condition and clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Serum Albumin From Oryza Sativa | Not described Receives: Drug: Recombinant Human Serum Albumin From Oryza Sativa |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of all adverse drug reactions
Measured: During treatment to a month after treatment
Secondary outcomes (5)
The incidence of all adverse events (AEs)
Measured: During treatment to a month after treatment
The incidence of serious adverse events.
Measured: During treatment to a month after treatment
The incidence of adverse events of special interest (AESIs).
Measured: 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.
Measured: During treatment to a month after treatment
Changes from baseline in serum albumin concentration.
Measured: One day after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start24 Feb 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoalbuminemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthgen Biotechnology Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435922
- Sponsor's protocol ID
- HY1001-2025-P4
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Serum Albumin From Oryza Sativa In Patients With Hypoalbuminemia and/or Hypovolemia Requiring Urgent Treatment: A ReaL World Observational Study
- ClinicalTrials.gov ID
- NCT07435922
- Acronym / sponsor ID
- HY1001-2025-P4
- Conditions
- Hypoalbuminemia, Hypovolemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Healthgen Biotechnology Corp.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Serum Albumin From Oryza Sativa | – | Drug: Recombinant Human Serum Albumin From Oryza Sativa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With Hypoalbuminemia and/or Hypovolemia Requiring Urgent Treatment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Serum Albumin From Oryza SativaThe treatment of the study drug will be solely determined by the attending physician based on the patient's condition and clinical guidelines. | Drug | Recombinant Human Serum Albumin From Oryza Sativa |
Primary outcome
incidence of all adverse drug reactions
Time frame: During treatment to a month after treatment
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
Related trials for Hypoalbuminemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Effect of Albumin Therapy in Mechanically Ventilated Patients With Sepsis-Associated ARDS
Acute Respiratory Distress Syndrome, Sepsis
Not yet recruitingPhase 1
A Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of GLR1075 Injection in Healthy Trial Participants and Cirrhotic Trial Participants With Ascites and Hypoalbuminemia
Hypoalbuminemia in Cirrhotic Ascites
Not yet recruitingObservational study
Impact of Hypoalbuminemia on Cefoperazone/Sulbactam Induced Coagulopathy in Post-Operative Surgical Patients
Cefoperazone/Sulbactam Induced Coagulopayjy
RecruitingPhase 4
Rice-derived Recombinant Human Serum Albumin for the Treatment of Hypoalbuminemia After Hepatectomy: A Prospective, Single-Arm, Exploratory Clinical Trial
Post-hepatectomy Hypoalbuminemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoalbuminemia and Hypovolemia, run by Healthgen Biotechnology Corp. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuemin Lan, MD (+86-185 3311 2266, nanyuemin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of all adverse drug reactions (time frame: During treatment to a month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.