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

NCT ID: NCT06275724

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

585 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-04

Study Completion Date

2026-12-17

Brief Summary

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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

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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

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Familial Hypercholesterolaemia Hypercholesterolaemia

Keywords

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familial hypercholesterolaemia hypercholesterolaemia FH HoFH Leqvio inclisiran sodium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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inclisiran

Patients prescribed with inclisiran

inclisiran

Intervention Type OTHER

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

Interventions

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inclisiran

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Handa, Aichi-ken, Japan

Site Status

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Ichinomiya, Aichi-ken, Japan

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Ichinomiya, Aichi-ken, Japan

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Komaki, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Toyoake, Aichi-ken, Japan

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Tsushima, Aichi-ken, Japan

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Asahi, Chiba, Japan

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Inzai, Chiba, Japan

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Urayasu, Chiba, Japan

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Matsuyama, Ehime, Japan

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Fukui-shi, Fukui, Japan

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Fukuoka, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Fukushima, Fukushima, Japan

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Kōriyama, Fukushima, Japan

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Shirakawa, Fukushima, Japan

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Gifu, Gifu, Japan

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Hiroshima, Hiroshima, Japan

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Kure, Hiroshima, Japan

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Asahikawa, Hokkaido, Japan

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Asahikawa, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Amagasaki, Hyōgo, Japan

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Himeji, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Ono, Hyōgo, Japan

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Takarazuka, Hyōgo, Japan

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Kamisu, Ibaraki, Japan

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Koga, Ibaraki, Japan

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Mito, Ibaraki, Japan

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Moriya, Ibaraki, Japan

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Tsukuba, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Kagoshima, Kagoshima-ken, Japan

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Fujisawa, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokosuka, Kanagawa, Japan

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Yokosuka, Kanagawa, Japan

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Yatsushiro, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Kyoto, Kyoto, Japan

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Kyōtanabe, Kyoto, Japan

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Tsu, Mie-ken, Japan

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Nagasaki, Nagasaki, Japan

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Nagasaki, Nagasaki, Japan

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Ōmura, Nagasaki, Japan

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Ikoma, Nara, Japan

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Kashihara, Nara, Japan

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Tenri, Nara, Japan

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Nagaoka, Niigata, Japan

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Ōita, Oita Prefecture, Japan

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Ōita, Oita Prefecture, Japan

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Ōita, Oita Prefecture, Japan

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Kurashiki, Okayama-ken, Japan

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Urasoe, Okinawa, Japan

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Uruma, Okinawa, Japan

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Izumisano, Osaka, Japan

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Moriguchi, Osaka, Japan

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Osaka, Osaka, Japan

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Osaka, Osaka, Japan

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Takatsuki, Osaka, Japan

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Takatsuki, Osaka, Japan

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Takatsuki, Osaka, Japan

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Toyonaka, Osaka, Japan

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Asaka, Saitama, Japan

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Gyōda, Saitama, Japan

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Iruma-gun, Saitama, Japan

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Kitamoto, Saitama, Japan

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Sōka, Saitama, Japan

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Tokorozawa, Saitama, Japan

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Nagahama, Shiga, Japan

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Izunokuni, Shizuoka, Japan

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Mooka, Tochigi, Japan

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Hachiōji, Tokyo, Japan

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Machida, Tokyo, Japan

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Meguro City, Tokyo, Japan

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Minato, Tokyo, Japan

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Nerima-ku, Tokyo, Japan

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Shinjuku, Tokyo, Japan

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Shinjuku Ku, Tokyo, Japan

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Sumida City, Tokyo, Japan

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Toshima-ku, Tokyo, Japan

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Takaoka, Toyama, Japan

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Hashimoto, Wakayama, Japan

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Sakata, Yamagata, Japan

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Yamagata, Yamagata, Japan

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Akita, , Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Fukushima, , Japan

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Himeji, , Japan

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Kagoshima, , Japan

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Kumamoto, , Japan

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Kyoto, , Japan

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Nara, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Shizuoka, , Japan

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Countries

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Japan

Other Identifiers

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CKJX839A11401

Identifier Type: -

Identifier Source: org_study_id