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

August 5, 2026 updated by: Novartis Pharmaceuticals

Specified Drug-use Survey of Leqvio for s.c. Injection (Familial Hypercholesterolaemia or Hypercholesterolaemia, CKJX839A11401)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

585

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Akita, Japan, 0108577
        • Novartis Investigative Site
      • Chiba, Japan, 261-0024
        • Novartis Investigative Site
      • Fukuoka, Japan, 811-0213
        • Novartis Investigative Site
      • Fukushima, Japan, 9601295
        • Novartis Investigative Site
      • Himeji, Japan, 671-1227
        • Novartis Investigative Site
      • Ishikawa, Japan, 9208641
        • Novartis Investigative Site
      • Kagoshima, Japan, 892-0853
        • Novartis Investigative Site
      • Kumamoto, Japan, 861-4193
        • Novartis Investigative Site
      • Kyoto, Japan, 6078062
        • Novartis Investigative Site
      • Nara, Japan, 630-8581
        • Novartis Investigative Site
      • Okayama, Japan, 7008558
        • Novartis Investigative Site
      • Osaka, Japan, 543-8555
        • Novartis Investigative Site
      • Osaka, Japan, 558-8558
        • Novartis Investigative Site
      • Osaka, Japan, 5458586
        • Novartis Investigative Site
      • Shizuoka, Japan, 422-8527
        • Novartis Investigative Site
    • Aichi-ken
      • Handa, Aichi-ken, Japan, 475-0817
        • Novartis Investigative Site
      • Ichinomiya, Aichi-ken, Japan, 491-8551
        • Novartis Investigative Site
      • Ichinomiya, Aichi-ken, Japan, 494-0001
        • Novartis Investigative Site
      • Komaki, Aichi-ken, Japan, 485-8520
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 4540933
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 461-0045
        • Novartis Investigative Site
      • Toyoake, Aichi-ken, Japan, 4701192
        • Novartis Investigative Site
      • Tsushima, Aichi-ken, Japan, 496-0038
        • Novartis Investigative Site
    • Chiba
      • Asahi, Chiba, Japan, 289-2511
        • Novartis Investigative Site
      • Inzai, Chiba, Japan, 270-1694
        • Novartis Investigative Site
      • Urayasu, Chiba, Japan, 279-0021
        • Novartis Investigative Site
    • Ehime
      • Matsuyama, Ehime, Japan, 791-8016
        • Novartis Investigative Site
    • Fukui
      • Fukui-shi, Fukui, Japan, 910-8526
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 8140180
        • Novartis Investigative Site
      • Fukuoka, Fukuoka, Japan, 815-0082
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 800-0031
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 8078556
        • Novartis Investigative Site
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-8611
        • Novartis Investigative Site
      • Kōriyama, Fukushima, Japan, 963-8501
        • Novartis Investigative Site
      • Shirakawa, Fukushima, Japan, 961-0005
        • Novartis Investigative Site
    • Gifu
      • Gifu, Gifu, Japan, 500-8384
        • Novartis Investigative Site
    • Hiroshima
      • Hiroshima, Hiroshima, Japan, 7320053
        • Novartis Investigative Site
      • Kure, Hiroshima, Japan, 737-0023
        • Novartis Investigative Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 0788211
        • Novartis Investigative Site
      • Asahikawa, Hokkaido, Japan, 0788214
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 065-0027
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 0040052
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 0620003
        • Novartis Investigative Site
    • Hyōgo
      • Amagasaki, Hyōgo, Japan, 660-8511
        • Novartis Investigative Site
      • Himeji, Hyōgo, Japan, 6708560
        • Novartis Investigative Site
      • Kobe, Hyōgo, Japan, 654-0026
        • Novartis Investigative Site
      • Ono, Hyōgo, Japan, 675-1327
        • Novartis Investigative Site
      • Takarazuka, Hyōgo, Japan, 665-0873
        • Novartis Investigative Site
    • Ibaraki
      • Kamisu, Ibaraki, Japan, 314-0146
        • Novartis Investigative Site
      • Koga, Ibaraki, Japan, 306-0232
        • Novartis Investigative Site
      • Mito, Ibaraki, Japan, 310-0015
        • Novartis Investigative Site
      • Moriya, Ibaraki, Japan, 302-0102
        • Novartis Investigative Site
      • Tsukuba, Ibaraki, Japan, 3058576
        • Novartis Investigative Site
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-8760
        • Novartis Investigative Site
    • Kanagawa
      • Fujisawa, Kanagawa, Japan, 252-0802
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 224-8503
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 235-0016
        • Novartis Investigative Site
      • Yokosuka, Kanagawa, Japan, 240-0101
        • Novartis Investigative Site
      • Yokosuka, Kanagawa, Japan, 239-8567
        • Novartis Investigative Site
    • Kumamoto
      • Yatsushiro, Kumamoto, Japan, 866-8533
        • Novartis Investigative Site
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-8566
        • Novartis Investigative Site
      • Kyoto, Kyoto, Japan, 612-8555
        • Novartis Investigative Site
      • Kyōtanabe, Kyoto, Japan, 610-0334
        • Novartis Investigative Site
    • Mie-ken
      • Tsu, Mie-ken, Japan, 5148507
        • Novartis Investigative Site
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 8508555
        • Novartis Investigative Site
      • Nagasaki, Nagasaki, Japan, 852-8055
        • Novartis Investigative Site
      • Ōmura, Nagasaki, Japan, 856-8562
        • Novartis Investigative Site
    • Nara
      • Ikoma, Nara, Japan, 636-0802
        • Novartis Investigative Site
      • Kashihara, Nara, Japan, 634-0045
        • Novartis Investigative Site
      • Tenri, Nara, Japan, 632-8552
        • Novartis Investigative Site
    • Niigata
      • Nagaoka, Niigata, Japan, 940-8621
        • Novartis Investigative Site
    • Oita Prefecture
      • Ōita, Oita Prefecture, Japan, 870-0263
        • Novartis Investigative Site
      • Ōita, Oita Prefecture, Japan, 870-1133
        • Novartis Investigative Site
      • Ōita, Oita Prefecture, Japan, 879-7761
        • Novartis Investigative Site
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan, 7108602
        • Novartis Investigative Site
    • Okinawa
      • Urasoe, Okinawa, Japan, 901-2102
        • Novartis Investigative Site
      • Uruma, Okinawa, Japan, 904-2293
        • Novartis Investigative Site
    • Osaka
      • Izumisano, Osaka, Japan, 5988577
        • Novartis Investigative Site
      • Moriguchi, Osaka, Japan, 570-8507
        • Novartis Investigative Site
      • Osaka, Osaka, Japan, 543-8922
        • Novartis Investigative Site
      • Osaka, Osaka, Japan, 5400006
        • Novartis Investigative Site
      • Takatsuki, Osaka, Japan, 569-0852
        • Novartis Investigative Site
      • Takatsuki, Osaka, Japan, 569-1121
        • Novartis Investigative Site
      • Takatsuki, Osaka, Japan, 5698686
        • Novartis Investigative Site
      • Toyonaka, Osaka, Japan, 560-0083
        • Novartis Investigative Site
    • Saitama
      • Asaka, Saitama, Japan, 3510021
        • Novartis Investigative Site
      • Gyōda, Saitama, Japan, 361-0056
        • Novartis Investigative Site
      • Iruma-gun, Saitama, Japan, 3500495
        • Novartis Investigative Site
      • Kitamoto, Saitama, Japan, 364-8501
        • Novartis Investigative Site
      • Sōka, Saitama, Japan, 340-0043
        • Novartis Investigative Site
      • Tokorozawa, Saitama, Japan, 359-1142
        • Novartis Investigative Site
    • Shiga
      • Nagahama, Shiga, Japan, 526-8580
        • Novartis Investigative Site
    • Shizuoka
      • Izunokuni, Shizuoka, Japan, 410-2295
        • Novartis Investigative Site
    • Tochigi
      • Mooka, Tochigi, Japan, 321-4306
        • Novartis Investigative Site
    • Tokyo
      • Hachiōji, Tokyo, Japan, 192-0918
        • Novartis Investigative Site
      • Machida, Tokyo, Japan, 194-0021
        • Novartis Investigative Site
      • Meguro City, Tokyo, Japan, 153-8515
        • Novartis Investigative Site
      • Minato, Tokyo, Japan, 106-0031
        • Novartis Investigative Site
      • Nerima-ku, Tokyo, Japan, 176-8530
        • Novartis Investigative Site
      • Shinjuku, Tokyo, Japan, 160-8488
        • Novartis Investigative Site
      • Shinjuku Ku, Tokyo, Japan, 1628666
        • Novartis Investigative Site
      • Sumida City, Tokyo, Japan, 130-8575
        • Novartis Investigative Site
      • Toshima-ku, Tokyo, Japan, 171-0014
        • Novartis Investigative Site
    • Toyama
      • Takaoka, Toyama, Japan, 939-1104
        • Novartis Investigative Site
    • Wakayama
      • Hashimoto, Wakayama, Japan, 648-0005
        • Novartis Investigative Site
    • Yamagata
      • Sakata, Yamagata, Japan, 998-8501
        • Novartis Investigative Site
      • Yamagata, Yamagata, Japan, 990-9585
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated with inclisiran

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
inclisiran
Patients prescribed with inclisiran
Other: inclisiran
Prospective observational study. There is no treatment allocation. Patients prescribed with inclisiran are eligible to enroll into this study.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Estimated)

December 17, 2026

Study Completion (Estimated)

December 17, 2026

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CKJX839A11401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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