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

N/AActive Not RecruitingNCT06275724

Novartis Pharmaceuticals585 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

585

Conditions

Familial Hypercholesterolaemia Hypercholesterolaemia

Interventions

inclisiranOTHER

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

Eligibility

Sex: ALLMin age: 15 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (107)

Outcomes

Primary Outcomes

Number of patients with adverse events

To evaluate the long-term safety profile of Leqvio

Time frame: Up to 24 months

Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions

To evaluate the long-term safety profile of Leqvio

Time frame: Up to 24 months

Secondary Outcomes

Number of patients with adverse events leading to discontinuation of treatment with the product

To evaluate the tolerability of Leqvio

Time frame: Up to 24 months

Percent change from baseline in LDL-C levels

To evaluate the efficacy of Leqvio based on LDL-C levels

Time frame: Month 24

Data from ClinicalTrials.gov

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Novartis Investigative Site

Handa, Aichi-ken, Japan

Novartis Investigative Site

Ichinomiya, Aichi-ken, Japan

Novartis Investigative Site

Ichinomiya, Aichi-ken, Japan

Novartis Investigative Site

Komaki, Aichi-ken, Japan

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Toyoake, Aichi-ken, Japan

Novartis Investigative Site

Tsushima, Aichi-ken, Japan

Novartis Investigative Site

Asahi, Chiba, Japan

Novartis Investigative Site

Inzai, Chiba, Japan

...and 97 more locations