A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B

Overview

About this study

This trial is conducted in Europe and the United States of America. The aim of this trial is to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male, aged 18-70 years (both inclusive) at the time of signing informed consent
  • Patients with the diagnosis of congenital haemophilia B with factor IX activity below or equal to 2%, based on medical records
  • History of more than 150 exposures days to any factor IX containing products

Exclusion Criteria:

  • Known history of factor IX inhibitors
  • Inhibitors to factor IX (above or equal to 0.6 BU) at screening measured by the Nijmegen modified Bethesda method
  • Immunocompromised (CD4+ T cells below or equal to 200/μL)
  • Known congenital or acquired coagulation disorders other than haemophilia B
  • Body mass index above 35 kg/m^²

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Rajiv Pruthi, M.B.B.S.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20356998

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