HypoalbuminemiaPhase 3NCT06355479
A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia
A Phase 3 study testing OsrHSA and Plasbumin®-20 in people with Hypoalbuminemia and Hepatic Cirrhosis, run by Healthgen Biotechnology Corp. at 37 sites in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of OsrHSA works to treat hypoalbuminemia in hepatic cirrhosis patients. It will also learn about the safety and immunogenicity of OsrHSA. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypoalbuminemia, Hepatic Cirrhosis
- What is being tested?
- OsrHSA and Plasbumin®-20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 37 sitesChina
- Study dates
- 10 Apr 2023to 12 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Diagnosis of hepatic cirrhosis
- Adult males or females, aged 18-75 years (both inclusive) at the time of consent
- Serum albumin level ≤ 30 g/L
- Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol
Main Exclusion Criteria:
- History of allergy to rice; a history of allergy to any component of the HpHSA product
- Therapeutic/ Large-volume paracentesis (> 5L each time) during the treatment period
- Ascites resulted from non-hepatic cirrhosis, Budd-Chiari syndrome
- Participants with Grade III or Grade IV hepatic encephalopathy using West Heaven Criteria
- A transjugular intrahepatic peritoneal shunt (TIPS) is performed within 1 month prior to the first dosing
- Evidence of upper gastrointestinal hemorrhage 6 months prior to the first dosing
- Participants with stage C and stage D hepatocellular carcinoma according to China Liver Cancer Staging (CNLC) Classification
- Evidence of extrahepatic neoplastic disorders
- Transplantation
- HIV positive
- Participants with pleural effusion and need therapeutic thoracentesis during the treatment period
- Uncontrolled infection with body temperature ≥ 38.5 degrees Celsius (101.3 degrees Fahrenheit) or ≤ 35 degrees Celsius (95 degrees Fahrenheit) and white blood cells > 12.0×10^9/L. i.e. severe intraabdominal infections, sepsis, respiratory tract infections, urine tract infections.
- Other serious underlying diseases, including but not limited to: hepatopulmonary syndrome, heart failure grade III-IV (NYHA scale of heart function), severe structural heart disease, symptomatic ischemic heart disease, severe chest and lung disease, hemodialysis, active biliary obstructive disease, etc.
- With the following abnormal laboratory test values: Hematology: white blood cell count < 2.0×10^9/L, absolute neutrophil count < 1.0×10^9/L, platelets < 30×10^9/L, or hemoglobin < 75 g/L; Chemistry: ALT and/or AST > 5× upper limit of normal (ULN), total bilirubin > 3× ULN; Coagulation: INR>2.0; Renal function: Cr > 2×ULN, urine protein >2+; Echocardiography: LVEF < 50%
- Pregnant or breastfeeding or plan to get pregnant in 6 months
- Potentially fertile participants (other than women who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or postmenopause for more than 1 year, and men who have undergone bilateral vasectomy) who do not consent to or are unable to use effective contraception throughout the study and 120 days after the end of the study (or early discontinuation of the study);
- Enrolled in any clinical trials within 3 months prior to the first dose of study intervention
- Any other condition that the investigator considers would make the participant unsuitable for the clinical trial
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
China37 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality
Hepatobiliary Hospital Of Jilin
Changchun, Jilin
The First Hospital of Jilin University
Changchun, Jilin
West China Hospital, Sichuan University
Chengdu, Sichuan
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi
Nanfang Hospital
Guangzhou, Guangdong
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
The Fourth Affiliated Hospital, Harbin Medical University
Harbin, Heilongjiang
Huizhou Central People's Hospital
Huizhou, Guangdong
Shandong Public Health Clinical Center
Jinan, Shandong
Jingzhou Central Hospital
Jingzhou, Hubei
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Liuzhou Worker's Hospital
Liuzhou, Guangxi
Luoyang Central Hospital
Luoyang, Henan
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Pingxiang People's Hospital
Pingxiang, Jiangxi
Ruian People's Hospital
Rui’an, Zhejiang
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning
TaiHe Hospital
Shiyan, Hubei
The First School of Medicine, School of Information and Engineering, The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
The Central Hospital of Wuhan
Wuhan, Hubei
Wuhan Jinyintan Hospital
Wuhan, Hubei
The People's Hospital of Qinghai
Xining, Qinghai
Yichang Central People's Hospital
Yichang, Hubei
Yichun People's Hospital
Yichun, Jiangxi
Yueyang Central Hospital
Yueyang, Hunan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan
The Third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu
Affiliated Hospital Of Zunyi Medical University
Zunyi, Guizhou
About this study
Official title: A Phase 3 Randomized, Double-blind, Active-controlled Multi-center Study to Evaluate the Efficacy, Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia
The goal of this clinical trial is to evaluate the efficacy of OsrHSA works to treat hypoalbuminemia in hepatic cirrhosis patients. It will also learn about the safety and immunogenicity of OsrHSA. The main question it aims to answer is whether OsrHSA is effective in elevating the serum albumin level of cirrhotic patients with hypoalbuminemia.
Researchers will compare OsrHSA to the positive comparator, plasma-derived HSA (pHSA) to see if OsrHSA presents as non-inferior to pHSA in the indication of hypoalbuminemia in hepatic cirrhosis patients.
Participants will be randomized in a 1:1 ratio to receive OsrHSA or HpHSA (20g IV qd) for up to 14 days, following an EOT visit. Follow-up visits will be taken on EOT+7d, EOT+14d, and EOT+30d, respectively.
- Conditions
- Hypoalbuminemia, Hepatic Cirrhosis
- Being tested
- OsrHSA, Plasbumin®-20
- Medical subject headings
- Hypoalbuminemia, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsrHSADrug
Recombinant Human Serum Albumin from Oryza Sativa
Plasbumin®-20Drug
Albumin (Human) 20%, USP
| Study group | Role | What they receive |
|---|---|---|
| OsrHSA | Experimental | OsrHSA 20g, IV qd, Day1 up to Day 14 Receives: Drug: OsrHSA |
| pHSA | Active comparator | pHSA 20g, IV qd, Day1 up to Day 14 Receives: Drug: Plasbumin®-20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of OsrHSA on elevating the serum albumin level.
Percentage of participants whose albumin level reaches 35 g/L or above at any time up to 14 days of the study intervention.
Measured: Day 1 to Day 14
Secondary outcomes (6)
To estimate the time to reach 35 g/L or more in serum albumin
Time to reach serum albumin 35 g/L or more by the end of the treatment (EOT)
Measured: Day 1 to Day 14
To estimate the change from baseline in serum albumin
To estimate the change from baseline to the end of treatment (EOT) in serum albumin
Measured: Day 1 to Day 14
To estimate the change from baseline in colloid osmotic pressure
The change from baseline to the end of treatment (EOT) will be measured in Colloid osmotic pressure
Measured: Day 1 to Day 14
To estimate the change from baseline in body weight
The change in body weight will be measured from baseline to the end of treatment (EOT)
Measured: Day 1 to Day 14
To estimate the change from baseline in abdominal circumference, and ascites severity
The change in abdominal circumferences will be measured from baseline to the end of treatment (EOT)
Measured: Day 1 to Day 14
To estimate the change from baseline in ascites severity
The change in ascites severity will be measured from baseline to the end of treatment (EOT)
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start10 Apr 2023
- Primary completion22 Nov 2023
- Study completion12 Dec 2023
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthgen Biotechnology Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355479
- Sponsor's protocol ID
- HY1001-2022-P3
- Status last verified
- Apr 2024
- First submitted
- 21 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-blind, Active-controlled Multi-center Study to Evaluate the Efficacy, Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia
- ClinicalTrials.gov ID
- NCT06355479
- Acronym / sponsor ID
- HY1001-2022-P3
- Conditions
- Hypoalbuminemia, Hepatic Cirrhosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Healthgen Biotechnology Corp.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 9 Apr 2024 (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.
The goal of this clinical trial is to evaluate the efficacy of OsrHSA works to treat hypoalbuminemia in hepatic cirrhosis patients. It will also learn about the safety and immunogenicity of OsrHSA. The main question it aims to answer is whether OsrHSA is effective in elevating the serum albumin level of cirrhotic patients with hypoalbuminemia.
Researchers will compare OsrHSA to the positive comparator, plasma-derived HSA (pHSA) to see if OsrHSA presents as non-inferior to pHSA in the indication of hypoalbuminemia in hepatic cirrhosis patients.
Participants will be randomized in a 1:1 ratio to receive OsrHSA or HpHSA (20g IV qd) for up to 14 days, following an EOT visit. Follow-up visits will be taken on EOT+7d, EOT+14d, and EOT+30d, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OsrHSA | Experimental | Drug: OsrHSAOsrHSA 20g, IV qd, Day1 up to Day 14 |
| pHSA | Active comparator | Drug: Plasbumin®-20pHSA 20g, IV qd, Day1 up to Day 14 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| OsrHSARecombinant Human Serum Albumin from Oryza Sativa | Drug | OsrHSA |
| Plasbumin®-20Albumin (Human) 20%, USP | Drug | pHSA |
Primary outcome
To evaluate the efficacy of OsrHSA on elevating the serum albumin level.
Time frame: Day 1 to Day 14
Percentage of participants whose albumin level reaches 35 g/L or above at any time up to 14 days of the study intervention.
6 secondary outcomes
To estimate the time to reach 35 g/L or more in serum albumin
Time frame: Day 1 to Day 14
To estimate the change from baseline in serum albumin
Time frame: Day 1 to Day 14
To estimate the change from baseline in colloid osmotic pressure
Time frame: Day 1 to Day 14
To estimate the change from baseline in body weight
Time frame: Day 1 to Day 14
To estimate the change from baseline in abdominal circumference, and ascites severity
Time frame: Day 1 to Day 14
To estimate the change from baseline in ascites severity
Time frame: Day 1 to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OsrHSA and Plasbumin®-20 in people with Hypoalbuminemia and Hepatic Cirrhosis, run by Healthgen Biotechnology Corp. at 37 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of OsrHSA on elevating the serum albumin level. (time frame: Day 1 to Day 14). 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 Apr 2024.