Novo Nordisk ((NVO)) announced an update on their ongoing clinical study.
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Study Overview: Novo Nordisk is conducting a post-marketing surveillance study titled Special Use-results Surveillance on Use of Alhemo in Patients With Haemophilia A or Haemophilia B Without Inhibitors. This multi-centre, open-label, non-interventional study aims to assess the long-term safety and clinical parameters of Alhemo in real-world clinical practice in Japan. The study is significant as it provides insights into the drug’s performance outside controlled clinical environments.
Intervention/Treatment: The study focuses on the drug Concizumab, commercially known as Alhemo. It is intended for patients with haemophilia A or B without inhibitors, administered according to routine clinical practice and physician discretion.
Study Design: This is an observational cohort study with a prospective time perspective. It does not involve random allocation or masking, as it aims to observe the natural outcomes of Alhemo treatment in a real-world setting.
Study Timeline: The study began on February 12, 2025, with an estimated duration of six years. Participant enrollment is expected to complete within the first four years, followed by a two-year observation period for each participant. The latest update was submitted on August 28, 2025, indicating ongoing progress.
Market Implications: This study update could positively influence Novo Nordisk’s stock performance by reinforcing investor confidence in Alhemo’s safety and effectiveness. As the study progresses, it may also impact the competitive landscape in the haemophilia treatment market, potentially affecting other companies with similar offerings.
The study is currently ongoing, with further details available on the ClinicalTrials portal.