Under construction – not a live service
Sign in
Taking peoplePhase 3

Tests ANB-002 in adults with hemophilia B

Tests the single-dose genetic treatment ANB-002 in adults with hemophilia B.

Key facts

Who runs it
Biocad
Where
Bangkok, ThailandSee the 3 sitesAlso in 1 other country, 11 sites
Trial code
Registry title
An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B
Status
Recruiting
Phase
Phase 3
People taking part
24 people, planned
Started
7 Nov 2024
Expected to end
Mar 2032
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • ANB-002
Record updated
18 November 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult men with hemophilia B, very low FIX activity, no FIX inhibitor, and long previous treatment with FIX concentrates.

Age
18 years or older
Sex
Men only
Disease stage
Hemophilia B with FIX activity ≤2%
Earlier treatment
Must have had at least 150 previous exposure days of treatment with FIX concentrates. Must never have had any gene therapy, including ANB-002.
Biomarker or test result
No FIX inhibitor. No anti-AAV5 antibodies.

Main reasons for not taking part

  • Any other disease of blood and blood-forming organs besides hemophilia B
  • Any earlier gene therapy, including ANB-002
  • HIV infection not controlled with anti-viral therapy, or active HBV or HCV infection
  • Serious liver disorders or signs of liver disease
  • Cancer with less than 5 years of remission

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Anti-AAV5 antibodies
  • 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
  • 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

Where in Thailand

Also in 1 other country, 11 sites

  • King Chulalongkorn Memorial HospitalBangkok, ThailandContact: Ponlapat RojnuckarinNot yet recruiting
  • Ramathibodi HospitalBangkok, ThailandContact: Pantep AngchaisuksiriNot yet recruiting
  • Siriraj HospitalBangkok, ThailandContact: Yingyong ChinnathammamitNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Lead-inNo study treatment, for comparison

    All subjects will be enrolled in the Lead-in period in order to collect information on individual bleeding rate anf FIX concentrates consumption

  • ANB-002 (arvenacogene sanparvovec)Treatment being tested

    After completion of lead-in period subjects will enter the main period which starts with ANB-002 (arvenacogene sanparvovec) infusion.

    Treatment: ANB-002

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B
Plain-language title
Tests ANB-002 in adults with hemophilia BGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
18 November 2025