ANB-002-2/MAGNOLIA, An Open-Label Comparative Study of the Efficacy, Safety, and Pharmacodynamics of ANB-002 when administered as a single dose to hemophilia B patients.
During the ANB-002-2/MAGNOLIA clinical trial, the efficacy, safety, and pharmacodynamics of the investigational drug ANB-002 will be evaluated following its single-dose administration to male clinical trial participants who:
Are aged 18 years and older.
Have a confirmed diagnosis of hemophilia B: FIX1 activity ≤ 2%.
Have no FIX inhibitor.
Received FIX concentrates for at least 150 days at the time of screening2.
Received FIX concentrates in prophylactic mode for not less than 12 months at the time of screening.
This clinical trial has non-inclusion criteria (criteria for non-eligibility to participate in a particular clinical trial); the full list will be provided to the potential participant by the Clinical Investigator. Among other factors, the non-inclusion criteria include the following:
A history of use of any gene therapy drug product.
Other diseases of the blood and hematopoietic organs, except hemophilia B.
Known allergy or intolerance to FIX concentrates, or glucocorticoids.
Diagnosed HIV infection (a participant diagnosed with HIV infection receiving antiretroviral therapy may participate in the clinical trial having an undetectable viral load < 50 copies/mL and CD4+3 count > 500 cells ×mm3).
Active hepatitis B (a participant who is negative for HBV4 DNA4 and negative for HBsAg5 may participate in the clinical trial).
Active hepatitis C (a participant who is negative for HCV5 RNA6 may participate in the clinical trial; a participant receiving antiviral therapy may participate in the clinical trial 12 weeks after completion of therapy).
All controversial cases regarding HIV infection, hepatitis B and C will be discussed with the clinical trial infectious disease specialist to determine the possibility of participation.
Prior arterial or venous thrombosis.
Diseases accompanied by significant immunosuppression.
Alcohol or drug addiction.
The CT participant may be provided with transportation services for the relevant trips, as well as accommodation services for undergoing visits within the ANB-002-2/MAGNOLIA clinical trial, if required, as agreed upon with the Clinical Investigator, and upon the CT participant’s consent. Reimbursement of transportation/accommodation costs associated with participation in the ANB-002-2/MAGNOLIA clinical trial is provided by JSC BIOCAD.
The ANB-002-2/MAGNOLIA clinical trial is being conducted in study centers located in different cities of the Russian Federation, including Moscow, St. Petersburg, Ufa, Samara, Chelyabinsk, Novosibirsk, and Kirov.
To query about participating in a clinical trial, including contact details of study centers, please use special form at ct.biocad.ru.
The Clinical Investigator will tell the potential participant about other eligibility criteria and contraindications to participation in this clinical trial. The potential participant should read the complete study information and consult with the Clinical Investigator and (or) Treating Physician.
Approval to conduct this clinical trial No. 529 dated November 07, 2024 provided by the Ministry of Health of the Russian Federation, as well as the list of approved study centers are published in the State Register of Medicines.
FIX: blood coagulation factor IX.
Screening is a specific time period aimed at the evaluation of a subject's eligibility to participate in a clinical trial according to the eligibility criteria based on the results of diagnostic procedures and expert opinions.
CD4+ are a type of T cells.
HBV DNA: qualitative determination of hepatitis B virus DNA (deoxyribonucleic acid).
HBsAg (hepatitis B virus (HBV) surface antigen) is the primary marker used to identify individuals infected with hepatitis B virus and to diagnose the disease.
HCV RNA: qualitative determination of hepatitis C virus RNA (ribonucleic acid).