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

Active, not recruiting

• Conditions: Hypercholesterolaemia; Familial Hypercholesterolaemia
• Interventions: Other: inclisiran

• Registration Number: NCT06275724
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Study Timeline

• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-02-16
• Study First Posted: 2024-02-23
• Study Start: 2024-03-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-14
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 583

Inclusion Criteria

• Patients who provided written informed consent to participate in this survey prior to the start of treatment with Leqvio.
• Patients who received treatment with Leqvio as per the package insert.

Exclusion Criteria

• Patients who received treatment with a formulation containing the same ingredients as Leqvio in the past.
• Patients participating in other interventional studies at the time of informed consent.
• Patients planning to participate in other interventional studies during this survey.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
inclisiran	inclisiran	Patients prescribed with inclisiran

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	Up to 24 months	To evaluate the long-term safety profile of Leqvio
Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions	Up to 24 months	To evaluate the long-term safety profile of Leqvio

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline in LDL-C levels	Month 24	To evaluate the efficacy of Leqvio based on LDL-C levels
Number of patients with adverse events leading to discontinuation of treatment with the product	Up to 24 months	To evaluate the tolerability of Leqvio

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Yamagata, Japan