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Tests treatment safety and results for Hemophilia B
Official title The Efficacy and Safety of ZS801 in Chinese Hemophilia B Patients.
ClinicalTrials.gov ID: NCT05630651
What this study is testing
What is ZS801?
ZS801 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hemophilia b.
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
- A non-randomized, open-label study to evaluate the safety, kinetics and efficacy of a single intravenous infusion of ZS801 in hemophilia B subjects with endogenous FIX ≤2%.
- 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 65, men only
You may be able to join if
- Male ≥18 years and ≤65years of age;
- Confirmed diagnosis of hemophilia B, and endogenous FIX ≤2%:
- Have had ≥100 prior exposure days (EDs) to any recombinant and/or plasma-derived FIX protein products;
- The subject had at least 3 or more bleeding events and/or chronic hemophilia arthritis in one or more joints in the previous 1 year requiring...
- Agree to use reliable barrier contraception and prohibition of sperm donation until 52 weeks after the administration of ZS801.
You likely can't join if
- Hypersensitivity to any component of the study drug (including immunosuppressants) or a condition that can not use;
- Inability to tolerate immunosuppressants or steroid drugs;
- Have FIX inhibitor as assessed by laboratory; or documented history of FIX inhibitor;
- Who have a history or are currently suffering from any of the following serious clinical diseases:
- History of malignancy or current presence of any malignancy;
- Have active autoimmune disease;
See the full eligibility criteria
- Male ≥18 years and ≤65years of age;
- Confirmed diagnosis of hemophilia B, and endogenous FIX ≤2%:
- Have had ≥100 prior exposure days (EDs) to any recombinant and/or plasma-derived FIX protein products;
- The subject had at least 3 or more bleeding events and/or chronic hemophilia arthritis in one or more joints in the previous 1 year requiring treatment with FIX agents;
- Agree to use reliable barrier contraception and prohibition of sperm donation until 52 weeks after the administration of ZS801.
- people voluntarily participate and are fully informed, fully understand the research and can comply with the requirements of the research protocol, are willing to complete the research as planned, and voluntarily...
- Hypersensitivity to any component of the study drug (including immunosuppressants) or a condition that can not use;
- Inability to tolerate immunosuppressants or steroid drugs;
- Have FIX inhibitor as assessed by laboratory; or documented history of FIX inhibitor;
- Who have a history or are currently suffering from any of the following serious clinical diseases:
- History of malignancy or current presence of any malignancy;
- Have active autoimmune disease;
- Severe heart disease, including angina pectoris, myocardial infarction, heart failure, clinically significant congenital heart disease, heart valve disease, arrhythmia and atrioventricular block, etc.;
- Have underlying liver disease or history of liver disease (such as portal hypertension, ascites, splenomegaly, esophageal varices, hepatic encephalopathy or hepatic fibrosis);
- Have HBsAg positive or HCV-Ab positive, or are currently receiving hepatitis B or hepatitis C antiviral therapy;
- Diabetes mellitus that is poorly controlled after drug treatment;
- Uncontrolled hypertension or hypotension;
- laboratory values:
- Hemoglobin\<110g/L;
- Platelets\<100×10\^9/L;
- aspartate aminotransferase, Alanine transaminase, alkaline phosphatase\>2×ULN;
- Total bilirubin\>1.5×ULN;
- Creatinine\>ULN;
- Albumin\<LLN;
- HIV antibody positive or Treponema pallidum antibody positive.
- Have AAV5 capsid neutralizing antibody titers \>1:640;
- Those who have received clinical trials of gene therapy before screening, or have used FIX clinical trial drugs within 1 month, or participated in other drug/device clinical trials within 3 months, or plan to...
- Those who have planned surgery within 52 weeks after the infusion;
- Those who lost more than 400 mL of blood within 3 months before screening;
- Those with epilepsy, history of mental illness (such as schizophrenia, depression, mania or anxiety) or obvious mental disorder, incapacitated or incapacitated by other reasons;
- Patients with a history of drug abuse or alcoholism;
- Investigators believe that people have poor compliance or are expected to be less likely to complete follow-up;
- There are clinically significant diseases or other reasons that the researcher and/or collaborators consider unsuitable to participate in this researcher.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 male, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, 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.