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

Recruiting
15 years of age
Both
Phase N/A

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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

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.

Eligibility

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 details

Familial Hypercholesterolaemia, Hypercholesterolaemia

NCT06275724

Novartis Pharmaceuticals

17 June 2024

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