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Tests treatment safety and results for Hemophilia B
Official title An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B
ClinicalTrials.gov ID: NCT06700096
What this study is testing
What is ANB-002?
ANB-002 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hemophilia b.
Also referred to as arvenacogene sanparvovec.
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 aim of the study is to demonstrate non-inferiority of ANB-002 compared with preventive use of coagulation factor IX (FIX) in adult subjects with hemophilia B with FIX activity ≤2% and without FIX inhibitor. The study will have an open-label single-arm design.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Men diagnosed with hemophilia B aged 18 or older
- FIX activity ≤2%
- Absense of FIX inhibitor
- ≥150 previous exposure days of treatment with FIX concentrates
You likely can't join if
- Any diseases of blood and hematopoietic organs other than hemophilia B
- A history of any gene therapy, including ANB-002
- Diagnosed HIV-infection, not controlled with anti-viral therapy
- Active HBV or HCV infection
- Anti-AAV5 antibodies
- Any active systemic infections or recurrent infections requiring systemic therapy
See the full eligibility criteria
- Men diagnosed with hemophilia B aged 18 or older
- FIX activity ≤2%
- Absense of FIX inhibitor
- ≥150 previous exposure days of treatment with FIX concentrates
- Any diseases of blood and hematopoietic organs other than hemophilia B
- A history of any gene therapy, including ANB-002
- Diagnosed HIV-infection, not controlled with anti-viral therapy
- Active HBV or HCV infection
- Anti-AAV5 antibodies
- Any active systemic infections or recurrent infections requiring systemic therapy
- Any other disorders associated with severe immunodeficiency
- Relevant hepatic disorders or conditions that can be a symptom of existing liver disorder
- Malignancies with less than 5 years of remission
The study team makes the final eligibility decision.
Where it's taking place
- Chelyabinsk, Russia
- Kirov, Russia
- Moscow, Russia
- Novosibirsk, Russia
- Saint Petersburg, Russia
- Samara, Russia
- Ufa, Russia
- Bangkok, Thailand
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chelyabinsk, Russia; Kirov, Russia; Moscow, Russia; Novosibirsk, Russia; Saint Petersburg, Russia; Samara, Russia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.