Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
ID04835480

A Phase II, Multicenter, Randomized, Positive-Controlled, Multi-Cohort Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites

Led by Healthgen Biotechnology Corp. · Updated on 2021-11-19

220

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy of intravenous OsrHSA compared to a positive control human serum albumin (HSA) in patients with decompensated cirrhotic ascites. This Phase II, multicenter, randomized, double-blind study aims to assess how well OsrHSA raises serum albumin levels and its safety and tolerability over a 14-day treatment period. Participants are stratified based on their baseline serum albumin levels to guide treatment continuation. Participants are randomly assigned in a 4:1 ratio to receive either OsrHSA or the positive control HSA at doses of 10 g or 20 g once daily via intravenous infusion for 14 days. The study includes multiple cohorts receiving these doses, with blinding maintained for both investigators and participants. Treatment may be stopped early if serum albumin levels reach 35 g/L or higher. After treatment, participants undergo three follow-up visits over two weeks to monitor progress. During the study, participants will be regularly evaluated for efficacy, safety, tolerability, and immune response to the treatments. Researchers will measure serum albumin levels to determine treatment effectiveness. The total participation duration includes up to 14 days of screening, 14 days of treatment, and follow-up visits over two weeks. The study tracks laboratory tests, clinical assessments, and adverse events to support comprehensive monitoring throughout the trial.

CONDITIONS

Brief Title

A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand and willing to sign the informed consent form
  • Diagnosed with decompensated cirrhosis and ascites by clinical, laboratory, or imaging evidence
  • Male or female aged 18 to 80 years
  • Serum albumin level of 30 g/L or less
  • Has adequate venous access
  • Female participants must be of non-childbearing potential or agree to use effective contraception as specified and have a negative pregnancy test at screening
  • Male participants who are sexually active with non-sterile female partners must agree to use double contraception methods and not donate sperm during the study
Not Eligible

You will not qualify if you...

  • Known allergy or severe reaction to cereal, rice, or any component of OsrHSA
  • Positive IgE or IgG antibodies against rice at screening
  • Medical conditions requiring albumin use other than hepatic cirrhosis, such as paracentesis-induced circulatory dysfunction or large-volume paracentesis
  • Nephrotic syndrome, hepatorenal syndrome, or elevated creatinine beyond twice the upper limit of normal
  • Significant heart or lung disease, hemodialysis, active gastrointestinal bleeding, or advanced hepatic encephalopathy
  • Malignant ascites or ascites caused by cancer
  • Advanced liver cancer (Grade C or D)
  • Pregnancy
  • HIV positive status
  • Active obstructive biliary tract disease
  • Abnormal lab values including low neutrophils, platelets, white blood cells, hemoglobin, high liver enzymes, bilirubin, or coagulation issues
  • Advanced heart failure (Stage C or D)
  • Previous organ transplant
  • Mental state preventing understanding of the study
  • Any condition deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 14 days

Participants receive OsrHSA or HSA via IV infusion once daily to treat decompensated cirrhotic ascites.

Daily visits for up to 14 days

Trial Site Locations

Total: 1 location

1

First Hospital of Jilin University

Changchun, Jilin, China

Actively Recruiting

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Research Team

H

Healthgen Wuhan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Rice-derived recombinant human serum albumin as an alternative to human plasma for patients with decompensated liver cirrhosis: a randomised, double-blind, positive-controlled and non-inferiority trial.

Junqi Niu, Yanhang Gao, Guiqiang Wang...

https://pubmed.ncbi.nlm.nih.gov/40555465