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Familial HypercholesterolaemiaNCT06275724

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

An observational study of Familial Hypercholesterolaemia and Hypercholesterolaemia, run by Novartis Pharmaceuticals at 107 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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 Read more about this study

Who is it for?
Ages 15 to 100 years
What is being tested?
inclisiran
How many people
585 participants
Where
107 sitesJapan
Study dates
4 Mar 2024to 17 Dec 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients treated with inclisiran

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

107 sites in 1 country.

107 sites in 1 country

Japan107 sites

  • Novartis Investigative Site

    Akita, 0108577

  • Novartis Investigative Site

    Amagasaki, Hyōgo, 660-8511

  • Novartis Investigative Site

    Asahi, Chiba, 289-2511

  • Novartis Investigative Site

    Asahikawa, Hokkaido, 0788211

  • Novartis Investigative Site

    Asahikawa, Hokkaido, 0788214

  • Novartis Investigative Site

    Asaka, Saitama, 3510021

  • Novartis Investigative Site

    Chiba, 261-0024

  • Novartis Investigative Site

    Fujisawa, Kanagawa, 252-0802

  • Novartis Investigative Site

    Fukui-shi, Fukui, 910-8526

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 8140180

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 815-0082

  • Novartis Investigative Site

    Fukuoka, 811-0213

  • Novartis Investigative Site

    Fukushima, Fukushima, 960-8611

  • Novartis Investigative Site

    Fukushima, 9601295

  • Novartis Investigative Site

    Gifu, Gifu, 500-8384

  • Novartis Investigative Site

    Gyōda, Saitama, 361-0056

  • Novartis Investigative Site

    Hachiōji, Tokyo, 192-0918

  • Novartis Investigative Site

    Handa, Aichi-ken, 475-0817

  • Novartis Investigative Site

    Hashimoto, Wakayama, 648-0005

  • Novartis Investigative Site

    Himeji, Hyōgo, 6708560

  • Novartis Investigative Site

    Himeji, 671-1227

  • Novartis Investigative Site

    Hiroshima, Hiroshima, 7320053

  • Novartis Investigative Site

    Ichinomiya, Aichi-ken, 491-8551

  • Novartis Investigative Site

    Ichinomiya, Aichi-ken, 494-0001

  • Novartis Investigative Site

    Ikoma, Nara, 636-0802

  • Novartis Investigative Site

    Inzai, Chiba, 270-1694

  • Novartis Investigative Site

    Iruma-gun, Saitama, 3500495

  • Novartis Investigative Site

    Ishikawa, 9208641

  • Novartis Investigative Site

    Izumisano, Osaka, 5988577

  • Novartis Investigative Site

    Izunokuni, Shizuoka, 410-2295

  • Novartis Investigative Site

    Kagoshima, Kagoshima-ken, 890-8760

  • Novartis Investigative Site

    Kagoshima, 892-0853

  • Novartis Investigative Site

    Kamisu, Ibaraki, 314-0146

  • Novartis Investigative Site

    Kashihara, Nara, 634-0045

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 800-0031

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 8078556

  • Novartis Investigative Site

    Kitamoto, Saitama, 364-8501

  • Novartis Investigative Site

    Kobe, Hyōgo, 654-0026

  • Novartis Investigative Site

    Koga, Ibaraki, 306-0232

  • Novartis Investigative Site

    Komaki, Aichi-ken, 485-8520

  • Novartis Investigative Site

    Kōriyama, Fukushima, 963-8501

  • Novartis Investigative Site

    Kumamoto, 861-4193

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 7108602

  • Novartis Investigative Site

    Kure, Hiroshima, 737-0023

  • Novartis Investigative Site

    Kyōtanabe, Kyoto, 610-0334

  • Novartis Investigative Site

    Kyoto, Kyoto, 602-8566

  • Novartis Investigative Site

    Kyoto, Kyoto, 612-8555

  • Novartis Investigative Site

    Kyoto, 6078062

  • Novartis Investigative Site

    Machida, Tokyo, 194-0021

  • Novartis Investigative Site

    Matsuyama, Ehime, 791-8016

  • Novartis Investigative Site

    Meguro City, Tokyo, 153-8515

  • Novartis Investigative Site

    Minato, Tokyo, 106-0031

  • Novartis Investigative Site

    Mito, Ibaraki, 310-0015

  • Novartis Investigative Site

    Mooka, Tochigi, 321-4306

  • Novartis Investigative Site

    Moriguchi, Osaka, 570-8507

  • Novartis Investigative Site

    Moriya, Ibaraki, 302-0102

  • Novartis Investigative Site

    Nagahama, Shiga, 526-8580

  • Novartis Investigative Site

    Nagaoka, Niigata, 940-8621

  • Novartis Investigative Site

    Nagasaki, Nagasaki, 8508555

  • Novartis Investigative Site

    Nagasaki, Nagasaki, 852-8055

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4540933

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 461-0045

  • Novartis Investigative Site

    Nara, 630-8581

  • Novartis Investigative Site

    Nerima-ku, Tokyo, 176-8530

  • Novartis Investigative Site

    Ōita, Oita Prefecture, 870-0263

  • Novartis Investigative Site

    Ōita, Oita Prefecture, 870-1133

  • Novartis Investigative Site

    Ōita, Oita Prefecture, 879-7761

  • Novartis Investigative Site

    Okayama, 7008558

  • Novartis Investigative Site

    Ōmura, Nagasaki, 856-8562

  • Novartis Investigative Site

    Ono, Hyōgo, 675-1327

  • Novartis Investigative Site

    Osaka, Osaka, 5400006

  • Novartis Investigative Site

    Osaka, Osaka, 543-8922

  • Novartis Investigative Site

    Osaka, 543-8555

  • Novartis Investigative Site

    Osaka, 5458586

  • Novartis Investigative Site

    Osaka, 558-8558

  • Novartis Investigative Site

    Sakata, Yamagata, 998-8501

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0040052

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0620003

  • Novartis Investigative Site

    Sapporo, Hokkaido, 065-0027

  • Novartis Investigative Site

    Shinjuku, Tokyo, 160-8488

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 1628666

  • Novartis Investigative Site

    Shirakawa, Fukushima, 961-0005

  • Novartis Investigative Site

    Shizuoka, 422-8527

  • Novartis Investigative Site

    Sōka, Saitama, 340-0043

  • Novartis Investigative Site

    Sumida City, Tokyo, 130-8575

  • Novartis Investigative Site

    Takaoka, Toyama, 939-1104

  • Novartis Investigative Site

    Takarazuka, Hyōgo, 665-0873

  • Novartis Investigative Site

    Takatsuki, Osaka, 569-0852

  • Novartis Investigative Site

    Takatsuki, Osaka, 569-1121

  • Novartis Investigative Site

    Takatsuki, Osaka, 5698686

  • Novartis Investigative Site

    Tenri, Nara, 632-8552

  • Novartis Investigative Site

    Tokorozawa, Saitama, 359-1142

  • Novartis Investigative Site

    Toshima-ku, Tokyo, 171-0014

  • Novartis Investigative Site

    Toyoake, Aichi-ken, 4701192

  • Novartis Investigative Site

    Toyonaka, Osaka, 560-0083

  • Novartis Investigative Site

    Tsu, Mie-ken, 5148507

  • Novartis Investigative Site

    Tsukuba, Ibaraki, 3058576

  • Novartis Investigative Site

    Tsushima, Aichi-ken, 496-0038

  • Novartis Investigative Site

    Urasoe, Okinawa, 901-2102

  • Novartis Investigative Site

    Urayasu, Chiba, 279-0021

  • Novartis Investigative Site

    Uruma, Okinawa, 904-2293

  • Novartis Investigative Site

    Yamagata, Yamagata, 990-9585

  • Novartis Investigative Site

    Yatsushiro, Kumamoto, 866-8533

  • Novartis Investigative Site

    Yokohama, Kanagawa, 224-8503

  • Novartis Investigative Site

    Yokohama, Kanagawa, 235-0016

  • Novartis Investigative Site

    Yokosuka, Kanagawa, 239-8567

  • Novartis Investigative Site

    Yokosuka, Kanagawa, 240-0101

Other trials in Japan

About this study

Official title: 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

Read the 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.

Being tested
inclisiran
Keywords
familial hypercholesterolaemia, hypercholesterolaemia, FH, HoFH, Leqvio, inclisiran sodium
Medical subject headings
Hyperlipoproteinemia Type II, Hypercholesterolemia, Homozygous Familial Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • inclisiranOther

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

Study groups in NCT06275724
Study groupRoleWhat they receive
inclisiranPatients prescribed with inclisiran
Receives: Other: inclisiran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with adverse events

    To evaluate the long-term safety profile of Leqvio

    Measured: Up to 24 months

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

    To evaluate the long-term safety profile of Leqvio

    Measured: Up to 24 months

Secondary outcomes (2)

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

    To evaluate the tolerability of Leqvio

    Measured: Up to 24 months

  2. Percent change from baseline in LDL-C levels

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

    Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start4 Mar 2024
  3. Primary completion17 Dec 2026 (estimated)
  4. Study completion17 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
585 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06275724
Sponsor's protocol ID
CKJX839A11401
Status last verified
Aug 2026
First submitted
16 Feb 2024
Last updated
6 Aug 2026
Results posted
No
Individual data sharing
No

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