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 ‘A Multi-centre, Open-label, Single-arm, Non-interventional Post-marketing Study to Investigate Safety and Clinical Parameters of Alhemo® Under Routine Clinical Practice in Japan.’ The study aims to assess the safety and effectiveness of Alhemo® (Concizumab) in patients with Haemophilia A or B with inhibitors, under real-world conditions in Japan. This research is significant as it provides insights into the drug’s performance outside controlled clinical trials.
Intervention/Treatment: The study focuses on Alhemo® (Concizumab), a drug intended for patients with Haemophilia A or B with inhibitors. Participants will receive Alhemo® as part of their routine clinical care, allowing researchers to observe its real-world application and outcomes.
Study Design: This observational study follows a case-only model with a prospective time perspective. It is designed to monitor the effects of Alhemo® in a real-world setting without intervention allocation or masking, emphasizing the collection of safety and effectiveness data.
Study Timeline: The study began on February 13, 2024, with an estimated completion date of 6.5 years from the start. The primary completion date is not specified, but the last update was submitted on August 28, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates on its findings.
Market Implications: The ongoing study of Alhemo® could influence Novo Nordisk’s stock performance by providing valuable data on the drug’s real-world effectiveness and safety. Positive results may enhance investor confidence and position Novo Nordisk favorably against competitors in the haemophilia treatment market, potentially impacting market dynamics and investor sentiment.
The study is currently ongoing, with further details available on the ClinicalTrials portal.