ANB-010

Originator investigational product
List of clinical studies

ANB-010-1/EDELWEISS A Two-Stage, Open-Label Study of the Safety, Pharmacodynamics, Biodistribution, Immunogenicity, and Efficacy of Single Dose ANB-010 in Subjects with Hemophilia A.

The clinical study ANB-010-1/EDELWEISS aimed to evaluate the safety, pharmacodynamics, biodistribution, immunogenicity and efficacy of ANB-010 in male patients who:

  • Are aged 18 years or older;
  • Have a confirmed diagnosis of hemophilia A with a documented history of endogenous FVIII activity ≤1% and ≤2% at screening1.
  • Have no history of or current FVIII inhibitor at screening (the presence of an inhibitor is considered confirmed with an inhibitor titer ≥0.6 BU);
  • Received FVIII concentrates for at least 150 days at the time of screening.

This study has exclusion criteria (precluding participation in this clinical study), which will all be explained to the potential participant by the study doctor. In particular, the exclusion criteria are:

  • A history of any gene therapy;
  • Use of emicizumab2;
  • Presence of other blood and hematopoietic organ diseases, except for hemophilia A.

If necessary, following agreement with the study doctor and consent of the clinical study participant or his/her legal representative, transportation services may be provided for trips required during the participation in this study. The study doctor will explain in detail the procedure of ordering transportation services to the clinical study participant or his/her legal representative. When transportation services are ordered, no information about the clinical study participant or his/her legal representative will be displayed, collected, or transmitted to the Sponsor.

The study ANB-010-1/EDELWEISS is carried out at study sites in different cities of the Russian Federation, such as Moscow, St. Petersburg, Ufa, Samara, Chelyabinsk, Kemerovo, Novosibirsk, Syktyvkar, Kirov, Yekaterinburg.

You can ask questions about participation in the clinical study and request contact information about the study sites using the special “Any questions?” form.

The study doctor will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study. The potential participant should read the full information about the study and consult the study doctor and/or attending physician.

Authorization of the Ministry of Health of the Russian Federation for this clinical study, No. 279 dated May 26, 2023, and the list of approved study centers have been published in the State Register of Medicines Register of authorizations to conduct clinical studies of medicinal products.

  • Screening is a pre-specified period aimed at assessing the possibility of participation of a subject in a clinical study according to the eligibility criteria, based on the results of diagnostic procedures and specialist consultations.
  • Emicizumab is a medicinal product for the treatment of hemophilia A) within less than 6 months before the date of signing of the Informed Consent.