NCT06275724

Specified Drug-use Survey of Leqvio for s.c. Injection.

Specified Drug-use Survey of Leqvio for s.c. Injection (Familial Hypercholesterolaemia or Hypercholesterolaemia, CKJX839A11401)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 585 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 15 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice

Detailed description

Uncontrolled, central registration system, multicenter, special drug use-results surveillance. This is a prospective, open-label, multicenter, single-arm observational study (non-interventional study: NIS) conducted only in Japan. The survey will include patients with familial hypercholesterolaemia or hypercholesterolaemia who have received treatment with Leqvio. Patients who discontinued treatment with Leqvio before completing the 24-month observation period will be followed for safety until the date of the last dose of Leqvio plus 180 days or until 24 months after the first dose of Leqvio, whichever comes earlier.

Conditions

• Familial Hypercholesterolaemia
• Hypercholesterolaemia

Interventions

Type	Name	Description
OTHER	inclisiran	Prospective observational study. There is no treatment allocation. Patients prescribed with inclisiran are eligible to enroll into this study.

Timeline

• Start date: 2024-03-04
• Primary completion: 2026-12-17
• Completion: 2026-12-17
• First posted: 2024-02-23
• Last updated: 2025-12-30

Locations

107 sites across 1 country: Japan