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

Novartis

Status

Active, not recruiting

Conditions

Familial Hypercholesterolaemia

Hypercholesterolaemia

Treatments

Other: inclisiran

Study type

Observational

Funder types

Industry

Identifiers

NCT06275724

CKJX839A11401

Details and patient eligibility

About

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

Full 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.

Enrollment

585 patients

Sex

All

Ages

15 to 100 years old

Volunteers

No Healthy Volunteers

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.