Post-hepatectomy HypoalbuminemiaPhase 4NCT07634549
Rice-derived Recombinant Human Serum Albumin for the Treatment of Hypoalbuminemia After Hepatectomy: A Prospective, Single-Arm, Exploratory Clinical Trial
A Phase 4 study testing Rice-derived recombinant human serum albumin (OsrHSA) in people with Post-hepatectomy Hypoalbuminemia, run by Cheng Qi at 1 site in China.
Trial summary
Rice-derived recombinant human serum albumin (OsrHSA) possesses an identical primary, secondary, and higher-order structure to plasma-derived human albumin. Through innovative production technology, it fundamentally circumvents the supply limitations and viral contamination risks associated with plasma sources… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-hepatectomy Hypoalbuminemia
- What is being tested?
- Rice-derived recombinant human serum albumin (OsrHSA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 31 Jul 2027
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and willing to sign the informed consent form.
- Male or female; age ≥18 years and ≤80 years.
- Planned for or has undergone hepatectomy.
- Developed postoperative hypoalbuminemia, defined as serum albumin ≤30 g/L .
Who cannot join
- Known hypersensitivity to the active ingredient or any excipient of the investigational drug
- Complicated with any of the following diseases or conditions: severe renal disease requiring hemodialysis, active upper gastrointestinal bleeding, hepatic encephalopathy Grade III or IV.
- Pregnant or lactating women.
- HIV positive.
- Heart failure classified as Stage C or D according to ACCF/AHA criteria.
- History of organ transplantation.
- Mental status that prevents the participant from understanding the nature, scope, and consequences of the study.
- Any clinical condition that the investigator considers makes the trial participant unsuitable for participation in the trial.
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, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qi Cheng, M.D., 13871459541, chengqi@hust.edu.cn
About this study
Rice-derived recombinant human serum albumin (OsrHSA) possesses an identical primary, secondary, and higher-order structure to plasma-derived human albumin. Through innovative production technology, it fundamentally circumvents the supply limitations and viral contamination risks associated with plasma sources, offering a novel solution to address clinical unmet needs. Existing research data have demonstrated that its efficacy and safety are non-inferior to plasma-derived human albumin in patients with cirrhosis complicated by hypoalbuminemia. However, no study has yet explored the safety and efficacy of OsrHSA in patients with postoperative hypoalbuminemia following hepatectomy. This study is a prospective, single-arm, small-sample, exploratory clinical trial aimed at evaluating the efficacy and safety of recombinant human serum albumin injection (rice) (OsrHSA) in patients with hypoalbuminemia after hepatectomy. All trial participants will receive daily intravenous infusion of 20 g OsrHSA (20%, 50 mL) starting from the day when postoperative hypoalbuminemia (<30 g/L) is identified, with concurrent monitoring of serum albumin levels. The primary endpoints are the percentage of trial participants achieving serum albumin ≥35 g/L within one week, and the incidence of adverse drug reactions.
- Conditions
- Post-hepatectomy Hypoalbuminemia
- Being tested
- Rice-derived recombinant human serum albumin (OsrHSA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice-derived recombinant human serum albumin (OsrHSA)Drug
All trial participants will receive daily intravenous infusion of 20 g Rice-derived recombinant human serum albumin (OsrHSA, 20%, 50 mL) starting from the day when postoperative hypoalbuminemia is identified, for a maximum duration of 7 days, with concurrent monitoring of serum albumin levels. Study drug administration will be discontinued once serum albumin reaches ≥35 g/L, and participants will enter the follow-up period. Each trial participant will undergo one follow-up visit within 30 days after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients receive daily intravenous infusion of 20 g rice-derived recombinant human serum albumin (OsrHSA, 20%, 50 mL) starting from the day when postoperative hypoalbuminemia (<30 g/L) is identified. Receives: Drug: Rice-derived recombinant human serum albumin (OsrHSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of trial participants achieving serum albumin ≥35 g/L within one week
Measured: one week after administrating rice-derived recombinant human serum albumin
Secondary outcomes (2)
Time to serum albumin ≥35 g/L (days)
Measured: one week after administrating rice-derived recombinant human serum albumin
adverse event
Measured: 30 days after administrating rice-derived recombinant human serum albumin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion7 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-hepatectomy 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng Qi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cheng Qi, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634549
- Sponsor's protocol ID
- HY1001-2026-IIT-01
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rice-derived Recombinant Human Serum Albumin for the Treatment of Hypoalbuminemia After Hepatectomy: A Prospective, Single-Arm, Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT07634549
- Acronym / sponsor ID
- HY1001-2026-IIT-01
- Conditions
- Post-hepatectomy Hypoalbuminemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cheng QiUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 7 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Jun 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.
Rice-derived recombinant human serum albumin (OsrHSA) possesses an identical primary, secondary, and higher-order structure to plasma-derived human albumin. Through innovative production technology, it fundamentally circumvents the supply limitations and viral contamination risks associated with plasma sources, offering a novel solution to address clinical unmet needs. Existing research data have demonstrated that its efficacy and safety are non-inferior to plasma-derived human albumin in patients with cirrhosis complicated by hypoalbuminemia. However, no study has yet explored the safety and efficacy of OsrHSA in patients with postoperative hypoalbuminemia following hepatectomy. This study is a prospective, single-arm, small-sample, exploratory clinical trial aimed at evaluating the efficacy and safety of recombinant human serum albumin injection (rice) (OsrHSA) in patients with hypoalbuminemia after hepatectomy. All trial participants will receive daily intravenous infusion of 20 g OsrHSA (20%, 50 mL) starting from the day when postoperative hypoalbuminemia (<30 g/L) is identified, with concurrent monitoring of serum albumin levels. The primary endpoints are the percentage of trial participants achieving serum albumin ≥35 g/L within one week, and the incidence of adverse drug reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Rice-derived recombinant human serum albumin (OsrHSA)Patients receive daily intravenous infusion of 20 g rice-derived recombinant human serum albumin (OsrHSA, 20%, 50 mL) starting from the day when postoperative hypoalbuminemia (<30 g/L) is identified. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to understand and willing to sign the informed consent form.
- Male or female; age ≥18 years and ≤80 years.
- Planned for or has undergone hepatectomy.
- Developed postoperative hypoalbuminemia, defined as serum albumin ≤30 g/L .
Key exclusion criteria (8 listed)
- Known hypersensitivity to the active ingredient or any excipient of the investigational drug
- Complicated with any of the following diseases or conditions: severe renal disease requiring hemodialysis, active upper gastrointestinal bleeding, hepatic encephalopathy Grade III or IV.
- Pregnant or lactating women.
- HIV positive.
- Heart failure classified as Stage C or D according to ACCF/AHA criteria.
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 |
|---|---|---|
| Rice-derived recombinant human serum albumin (OsrHSA)All trial participants will receive daily intravenous infusion of 20 g Rice-derived recombinant human serum albumin (OsrHSA, 20%, 50 mL) starting from the day when postoperative hypoalbuminemia is identified, for a maximum duration of 7 days, with concurrent monitoring of serum albumin levels. Study drug administration will be discontinued once serum albumin reaches ≥35 g/L, and participants will enter the follow-up period. Each trial participant will undergo one follow-up visit within 30 days after treatment. | Drug | Treatment group |
Primary outcome
The percentage of trial participants achieving serum albumin ≥35 g/L within one week
Time frame: one week after administrating rice-derived recombinant human serum albumin
2 secondary outcomes
Time to serum albumin ≥35 g/L (days)
Time frame: one week after administrating rice-derived recombinant human serum albumin
adverse event
Time frame: 30 days after administrating rice-derived recombinant human serum albumin
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 9 Jun 2026.
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?
A Phase 4 study testing Rice-derived recombinant human serum albumin (OsrHSA) in people with Post-hepatectomy Hypoalbuminemia, run by Cheng Qi 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 8 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: looking for participants now, as of the sponsor's last update on 9 Jun 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qi Cheng, M.D. (13871459541, chengqi@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of trial participants achieving serum albumin ≥35 g/L within one week (time frame: one week after administrating rice-derived recombinant human serum albumin). 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 9 Jun 2026.