## Protocol Section
### Identification Module
**NCT ID:** NCT06355479

**Brief Title:** A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia

**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

#### Organization Study ID Info
**ID:** HY1001-2022-P3
#### Organization
**Class:** INDUSTRY
**Full Name:** Healthgen Biotechnology Corp.
### Status Module
#### Completion Date
**Date:** 2023-12-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-09

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-11-22

**Type:** ACTUAL

#### Start Date
**Date:** 2023-04-10

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-04-09
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-21
**Study First Submit QC Date:** 2024-04-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Healthgen Biotechnology Corp.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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. 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 Module

**Conditions:**

- Hypoalbuminemia

- Hepatic Cirrhosis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 328

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** OsrHSA 20g, IV qd, Day1 up to Day 14

**Intervention Names:**

- Drug: OsrHSA

**Label:** OsrHSA

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** pHSA 20g, IV qd, Day1 up to Day 14

**Intervention Names:**

- Drug: Plasbumin®-20

**Label:** pHSA

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- OsrHSA

**Description:** Recombinant Human Serum Albumin from Oryza Sativa

**Name:** OsrHSA

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- pHSA

**Description:** Albumin (Human) 20%, USP

**Name:** Plasbumin®-20

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of participants whose albumin level reaches 35 g/L or above at any time up to 14 days of the study intervention.

**Measure:** To evaluate the efficacy of OsrHSA on elevating the serum albumin level.

**Time Frame:** Day 1 to Day 14

#### Secondary Outcomes

**Description:** Time to reach serum albumin 35 g/L or more by the end of the treatment (EOT)

**Measure:** To estimate the time to reach 35 g/L or more in serum albumin

**Time Frame:** Day 1 to Day 14

**Description:** To estimate the change from baseline to the end of treatment (EOT) in serum albumin

**Measure:** To estimate the change from baseline in serum albumin

**Time Frame:** Day 1 to Day 14

**Description:** The change from baseline to the end of treatment (EOT) will be measured in Colloid osmotic pressure

**Measure:** To estimate the change from baseline in colloid osmotic pressure

**Time Frame:** Day 1 to Day 14

**Description:** The change in body weight will be measured from baseline to the end of treatment (EOT)

**Measure:** To estimate the change from baseline in body weight

**Time Frame:** Day 1 to Day 14

**Description:** The change in abdominal circumferences will be measured from baseline to the end of treatment (EOT)

**Measure:** To estimate the change from baseline in abdominal circumference, and ascites severity

**Time Frame:** Day 1 to Day 14

**Description:** The change in ascites severity will be measured from baseline to the end of treatment (EOT)

**Measure:** To estimate the change from baseline in ascites severity

**Time Frame:** Day 1 to Day 14

### Eligibility Module

**Eligibility Criteria:** Main Inclusion Criteria:

1. Diagnosis of hepatic cirrhosis
2. Adult males or females, aged 18-75 years (both inclusive) at the time of consent
3. Serum albumin level ≤ 30 g/L
4. 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:

1. History of allergy to rice; a history of allergy to any component of the HpHSA product
2. Therapeutic/ Large-volume paracentesis (\> 5L each time) during the treatment period
3. Ascites resulted from non-hepatic cirrhosis, Budd-Chiari syndrome
4. Participants with Grade III or Grade IV hepatic encephalopathy using West Heaven Criteria
5. A transjugular intrahepatic peritoneal shunt (TIPS) is performed within 1 month prior to the first dosing
6. Evidence of upper gastrointestinal hemorrhage 6 months prior to the first dosing
7. Participants with stage C and stage D hepatocellular carcinoma according to China Liver Cancer Staging (CNLC) Classification
8. Evidence of extrahepatic neoplastic disorders
9. Transplantation
10. HIV positive
11. Participants with pleural effusion and need therapeutic thoracentesis during the treatment period
12. 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.
13. 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.
14. 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%
15. Pregnant or breastfeeding or plan to get pregnant in 6 months
16. 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);
17. Enrolled in any clinical trials within 3 months prior to the first dose of study intervention
18. Any other condition that the investigator considers would make the participant unsuitable for the clinical trial

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** Beijing Friendship Hospital, Capital Medical University

**State:** Beijing

**Location 2:**

**City:** Beijing

**Country:** China

**Facility:** Beijing Youan Hospital, Capital Medical University

**State:** Beijing

**Location 3:**

**City:** Chongqing

**Country:** China

**Facility:** Chongqing University Three Gorges Hospital

**State:** Chongqing

**Location 4:**

**City:** Chongqing

**Country:** China

**Facility:** The Second Affiliated Hospital of Chongqing Medical University

**State:** Chongqing

**Location 5:**

**City:** Fuzhou

**Country:** China

**Facility:** Mengchao Hepatobiliary Hospital of Fujian Medical University

**State:** Fujian

**Location 6:**

**City:** Fuzhou

**Country:** China

**Facility:** The First Affiliated Hospital of Fujian Medical University

**State:** Fujian

**Location 7:**

**City:** Guangzhou

**Country:** China

**Facility:** Nanfang Hospital

**State:** Guangdong

**Location 8:**

**City:** Guangzhou

**Country:** China

**Facility:** The Third Affiliated Hospital, Sun Yat-Sen University

**State:** Guangdong

**Location 9:**

**City:** Huizhou

**Country:** China

**Facility:** Huizhou Central People's Hospital

**State:** Guangdong

**Location 10:**

**City:** Guilin

**Country:** China

**Facility:** Affiliated Hospital of Guilin Medical University

**State:** Guangxi

**Location 11:**

**City:** Liuzhou

**Country:** China

**Facility:** Liuzhou Worker's Hospital

**State:** Guangxi

**Location 12:**

**City:** Nanning

**Country:** China

**Facility:** The First Affiliated Hospital of Guangxi Medical University

**State:** Guangxi

**Location 13:**

**City:** Zunyi

**Country:** China

**Facility:** Affiliated Hospital Of Zunyi Medical University

**State:** Guizhou

**Location 14:**

**City:** Harbin

**Country:** China

**Facility:** The Fourth Affiliated Hospital, Harbin Medical University

**State:** Heilongjiang

**Location 15:**

**City:** Luoyang

**Country:** China

**Facility:** Luoyang Central Hospital

**State:** Henan

**Location 16:**

**City:** Zhengzhou

**Country:** China

**Facility:** The First Affiliated Hospital of Zhengzhou University

**State:** Henan

**Location 17:**

**City:** Zhengzhou

**Country:** China

**Facility:** The Sixth People's Hospital of Zhengzhou

**State:** Henan

**Location 18:**

**City:** Jingzhou

**Country:** China

**Facility:** Jingzhou Central Hospital

**State:** Hubei

**Location 19:**

**City:** Shiyan

**Country:** China

**Facility:** TaiHe Hospital

**State:** Hubei

**Location 20:**

**City:** Wuhan

**Country:** China

**Facility:** The Central Hospital of Wuhan

**State:** Hubei

**Location 21:**

**City:** Wuhan

**Country:** China

**Facility:** Wuhan Jinyintan Hospital

**State:** Hubei

**Location 22:**

**City:** Yichang

**Country:** China

**Facility:** Yichang Central People's Hospital

**State:** Hubei

**Location 23:**

**City:** Yueyang

**Country:** China

**Facility:** Yueyang Central Hospital

**State:** Hunan

**Location 24:**

**City:** Zhenjiang

**Country:** China

**Facility:** The Third People's Hospital of Zhenjiang

**State:** Jiangsu

**Location 25:**

**City:** Ganzhou

**Country:** China

**Facility:** First Affiliated Hospital of Gannan Medical University

**State:** Jiangxi

**Location 26:**

**City:** Nanchang

**Country:** China

**Facility:** The First Affiliated Hospital of Nanchang University

**State:** Jiangxi

**Location 27:**

**City:** Pingxiang

**Country:** China

**Facility:** Pingxiang People's Hospital

**State:** Jiangxi

**Location 28:**

**City:** Yichun

**Country:** China

**Facility:** Yichun People's Hospital

**State:** Jiangxi

**Location 29:**

**City:** Chang chun

**Country:** China

**Facility:** Hepatobiliary Hospital Of Jilin

**State:** Jilin

**Location 30:**

**City:** Chang chun

**Country:** China

**Facility:** The First Hospital of Jilin University

**State:** Jilin

**Location 31:**

**City:** Shenyang

**Country:** China

**Facility:** The Sixth People's Hospital of Shenyang

**State:** Liaoning

**Location 32:**

**City:** Xining

**Country:** China

**Facility:** The People's Hospital of Qinghai

**State:** Qinghai

**Location 33:**

**City:** Jinan

**Country:** China

**Facility:** Shandong Public Health Clinical Center

**State:** Shandong

**Location 34:**

**City:** Chengdu

**Country:** China

**Facility:** West China Hospital, Sichuan University

**State:** Sichuan

**Location 35:**

**City:** Kunming

**Country:** China

**Facility:** The Second Affiliated Hospital of Kunming Medical University

**State:** Yunnan

**Location 36:**

**City:** Rui'an

**Country:** China

**Facility:** Ruian People's Hospital

**State:** Zhejiang

**Location 37:**

**City:** Wenzhou

**Country:** China

**Facility:** The First School of Medicine, School of Information and Engineering, The First Affiliated Hospital of Wenzhou Medical University

**State:** Zhejiang

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000007019

- Term: Hypoproteinemia

- ID: D000001796

- Term: Blood Protein Disorders

- ID: D000006402

- Term: Hematologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

### Condition Browse Module - Browse Leaves

- ID: M11103

- Name: Liver Cirrhosis

- Relevance: HIGH

- As Found: Hepatic Cirrhosis

- ID: M24397

- Name: Hypoalbuminemia

- Relevance: HIGH

- As Found: Hypoalbuminemia

- ID: M8485

- Name: Fibrosis

- Relevance: HIGH

- As Found: Cirrhosis

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10069

- Name: Hypoproteinemia

- Relevance: LOW

- As Found: Unknown

- ID: M5077

- Name: Blood Protein Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008103

- Term: Liver Cirrhosis

- ID: D000034141

- Term: Hypoalbuminemia

- ID: D000005355

- Term: Fibrosis

### Misc Info Module

- Version Holder: 2024-05-24
