Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT05152732
Eligibility Criteria:
Inclusion Criteria:
1. Male ≥18 years and ≤75years of age;
2. Confirmed diagnosis of hemophilia B (baseline FIX activity ≤ 2% of normal or documented history of FIX activity ≤2%);
3. At least 100 days exposure history to FIX;
4. Currently receiving FIX Prophylaxis therapy or on-demand treatment to prevent bleeding;
5. Have acceptable laboratory values:
1. Hemoglobin ≥110 g/L;
2. Platelets ≥100×10'9 cells/L;
3. AST, ALT, alkaline phosphatase ≤2×upper limit of normal (ULN) at the testing laboratory;
4. Bilirubin ≤3× ULN ;
5. Creatinine ≤1.5× ULN.
6. No measurable factor IX inhibitor as assessed by the central laboratory and have no prior history of inhibitors to factor IX protein;
7. Agree to use reliable barrier contraception until 3 consecutive samples are negative for vector sequences;
8. Able to provide informed consent and comply with the requirements of the study.
Exclusion Criteria:
1. Have significant underlying liver disease within the past 6 months prior to or at Screening, including but not limited to:
1. Preexisting diagnosis of portal hypertension;
2. Splenomegaly;
3. Encephalopathy;
4. Reduction of serum albumin;
5. Evidence of significant liver fibrosis;
2. Have anti-VGB-R04 neutralizing antibody titers ≥1:5;
3. Evidence of severe infection disease, i.e., human immunodeficiency virus (HIV) infection, syphilis, tuberculosis, etc.;
4. Evidence of active hepatitis B virus infection (HBV-DNA \>103 IU/ml) or hepatitis C virus infection (HCV antigen and HCV-RNA positive);
5. Evidence of malignant tumours or those with a previous history of malignant tumours;
6. Have a history of chronic infection or other chronic diseases that the Investigator considers to constitute an unacceptable risk;
7. Any immunodeficiency;
8. Participated in a gene transfer trial within the last 52 weeks or in a clinical trial with an investigational drug within the last 4 weeks;
9. Have used glucocorticoids, immunosuppressive drugs, or antipsychotics within the last 3 months;
10. Previous history of hypersensitivity or allergic reaction to any FIX products or any immunoglobulin;
11. Unable or unwilling to comply with the schedule of visits and study assessments described in the clinical protocol;
12. Any concurrent clinically significant major disease or any other condition that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05152732
Study Brief:
Protocol Section:
NCT05152732