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New treatment option for Cirrhotic Ascites
Official title A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites
ClinicalTrials.gov ID: NCT04835480
What this study is testing
What is OrsHSA?
OrsHSA is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cirrhotic ascites.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is designed to study the efficacy of IV OsrHSA or positive control HSA (10 g and 20 g IV everyday) for 14 days. After a screening period of up to 14 days, the eligible subjects will be randomized in a 4:1 ratio to OsrHSA and positive control HSA, respectively, in each cohort.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Able to understand and willing to sign the ICF;
- Decompensated cirrhosis with ascites by clinical, laboratory, or imaging evidence. Male or female eligible; Age ≥18 years and ≤80 years;
- Serum albumin ≤30 g/L;
- Has adequate venous access;
- Be a female of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal...
You likely can't join if
- Previous known allergic/adverse reaction to cereal or any food containing cereal, including rice; A history of a severe allergic reaction to any...
- Positive IgE and IgG against rice at the screening, i.e. anti-rice Ig E ≥ 0.35 kU/L and anti-rice Ig G ≥ 25.0 mgA/L;
- people who have medical conditions except for hepatic cirrhosis, currently requiring the use of albumin such as paracentesis-induced circulatory...
- Nephrotic syndrome, hepatorenal syndrome or Creatinine \>2 × upper limit of normal (ULN), significant cardiopulmonary or structural heart disease...
- Malignant ascites or ascites caused by cancer embolus;
- people with Grade C or D liver cancer according to the Barcelona-Clinic Liver Cancer staging (See Appendix 6);
See the full eligibility criteria
- Able to understand and willing to sign the ICF;
- Decompensated cirrhosis with ascites by clinical, laboratory, or imaging evidence. Male or female eligible; Age ≥18 years and ≤80 years;
- Serum albumin ≤30 g/L;
- Has adequate venous access;
- Be a female of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal and has a follicle stimulating hormone \> 40mIU/mL, or surgically...
- Practicing abstinence;
- If a sexually active woman of childbearing potential (sexually active with a non-sterile male partner) agrees to prevent pregnancy by using double methods of contraception as follow until at least 90 days after the...
- simultaneous use of the intrauterine contraceptive device, placed at least 4 weeks prior to study drug administration, and condom for the male partner;
- simultaneous use of hormonal contraceptives, starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner;
- simultaneous use of a diaphragm with intravaginally applied spermicide and male condoms for the male partner, starting at least 21 days prior to study drug administration.
- Male people who are not vasectomized for at least 6 months and who are sexually active with a non-sterile female partner must agree to use double methods of contraception below from the first dose of assigned by chance...
- simultaneous use of a male condom and, for the female partner, hormonal contraceptives (used since at least 4 weeks) or intrauterine contraceptive device (placed since at least 4 weeks);
- simultaneous use of a male condom and, for the female partner, a diaphragm with intravaginally applied spermicide.
- Previous known allergic/adverse reaction to cereal or any food containing cereal, including rice; A history of a severe allergic reaction to any HpHSA component or any food;
- Positive IgE and IgG against rice at the screening, i.e. anti-rice Ig E ≥ 0.35 kU/L and anti-rice Ig G ≥ 25.0 mgA/L;
- people who have medical conditions except for hepatic cirrhosis, currently requiring the use of albumin such as paracentesis-induced circulatory dysfunction, large- volume paracentesis (\>5 L each time);
- Nephrotic syndrome, hepatorenal syndrome or Creatinine \>2 × upper limit of normal (ULN), significant cardiopulmonary or structural heart disease, hemodialysis, active upper gastrointestinal bleeding, people with...
- Malignant ascites or ascites caused by cancer embolus;
- people with Grade C or D liver cancer according to the Barcelona-Clinic Liver Cancer staging (See Appendix 6);
- Pregnancy;
- HIV positive;
- Active obstructive disease in the biliary tract defined by ultrasound or other imaging modalities;
- With the following abnormal laboratory test values: Absolute neutrophil count (NE#) \ 5 × ULN, total bilirubin \> 5.0 ×ULN; PT INR \> 2.0; Urine protein \> 2+;
- people with Stage C or D heart failure according to ACCF/AHA Stage (See Appendix 7);
- Previous transplant;
- The mental state that prevents the subject from understanding the nature, extent, and consequences of the study;
- Any clinical condition that the Investigator considers would make the subject unsuitable for the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.