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

NCT06275724 | Active Not Recruiting

• 1 other identifier: CKJX839A11401
• Study Type: observational
• Target: 585
• Locations: 1 country
• Sites: 106

Brief 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

Conditions

Familial Hypercholesterolaemia; Hypercholesterolaemia

Keywords

familial hypercholesterolaemia; hypercholesterolaemia; FH; HoFH; Leqvio; inclisiran sodium

Outcome Measures

Primary Outcomes (2)

• Number of patients with adverse events

  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

  To evaluate the long-term safety profile of Leqvio

  Up to 24 months

Secondary Outcomes (2)

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

  Up to 24 months

• Percent change from baseline in LDL-C levels

  Month 24

Study Arms (1)

inclisiran

Patients prescribed with inclisiran

Other: inclisiran

Interventions

inclisiran OTHER

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

inclisiran

Eligibility Criteria

• Age: 15 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with inclisiran

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (106)

Novartis Investigative Site

Handa, Aichi-ken, 475-0817, Japan

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Ichinomiya, Aichi-ken, 491-8551, Japan

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Ichinomiya, Aichi-ken, 494-0001, Japan

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Komaki, Aichi-ken, 485-8520, Japan

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Nagoya, Aichi-ken, 4540933, Japan

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Nagoya, Aichi-ken, 461-0045, Japan

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Toyoake, Aichi-ken, 4701192, Japan

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Tsushima, Aichi-ken, 496-0038, Japan

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Asahi, Chiba, 289-2511, Japan

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Inzai, Chiba, 270-1694, Japan

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Urayasu, Chiba, 279-0021, Japan

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Matsuyama, Ehime, 791-8016, Japan

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Fukui-shi, Fukui, 910-8526, Japan

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Fukuoka, Fukuoka, 8140180, Japan

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Fukuoka, Fukuoka, 815-0082, Japan

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Kitakyushu, Fukuoka, 800-0031, Japan

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Kitakyushu, Fukuoka, 8078556, Japan

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Fukushima, Fukushima, 960-8611, Japan

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Kōriyama, Fukushima, 963-8501, Japan

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Shirakawa, Fukushima, 961-0005, Japan

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Gifu, Gifu, 500-8384, Japan

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Hiroshima, Hiroshima, 7320053, Japan

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Kure, Hiroshima, 737-0023, Japan

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Asahikawa, Hokkaido, 078-8214, Japan

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Asahikawa, Hokkaido, 0788211, Japan

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Sapporo, Hokkaido, 0040052, Japan

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Sapporo, Hokkaido, 0620003, Japan

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Sapporo, Hokkaido, 065-0027, Japan

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Amagasaki, Hyōgo, 660-8511, Japan

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Himeji, Hyōgo, 670-8560, Japan

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Kobe, Hyōgo, 654-0026, Japan

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Ono, Hyōgo, 675-1327, Japan

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Takarazuka, Hyōgo, 665-0873, Japan

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Kamisu, Ibaraki, 314-0146, Japan

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Koga, Ibaraki, 306-0232, Japan

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Mito, Ibaraki, 310-0015, Japan

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Moriya, Ibaraki, 302-0102, Japan

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Tsukuba, Ibaraki, 3058576, Japan

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Kagoshima, Kagoshima-ken, 890-8760, Japan

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Fujisawa, Kanagawa, 252-0802, Japan

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Yokohama, Kanagawa, 224-8503, Japan

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Yokohama, Kanagawa, 235-0016, Japan

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Yokosuka, Kanagawa, 239-8567, Japan

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Yokosuka, Kanagawa, 240-0101, Japan

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Yatsushiro, Kumamoto, 866-8533, Japan

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Kyoto, Kyoto, 602-8566, Japan

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Kyoto, Kyoto, 612-8555, Japan

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Kyōtanabe, Kyoto, 610-0334, Japan

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Tsu, Mie-ken, 514-8507, Japan

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Nagasaki, Nagasaki, 8508555, Japan

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Nagasaki, Nagasaki, 852-8055, Japan

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Ōmura, Nagasaki, 856-8562, Japan

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Ikoma, Nara, 636-0802, Japan

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Kashihara, Nara, 634-0045, Japan

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Tenri, Nara, 632-8552, Japan

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Nagaoka, Niigata, 940-8621, Japan

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Ōita, Oita Prefecture, 870-0263, Japan

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Ōita, Oita Prefecture, 870-1133, Japan

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Ōita, Oita Prefecture, 879-7761, Japan

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Kurashiki, Okayama-ken, 7108602, Japan

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Urasoe, Okinawa, 901-2102, Japan

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Uruma, Okinawa, 904-2293, Japan

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Izumisano, Osaka, 5988577, Japan

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Moriguchi, Osaka, 570-8507, Japan

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Osaka, Osaka, 5400006, Japan

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Osaka, Osaka, 543-8922, Japan

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Novartis Investigative Site

Takatsuki, Osaka, 569-0852, Japan

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Novartis Investigative Site

Takatsuki, Osaka, 569-1121, Japan

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Takatsuki, Osaka, 5698686, Japan

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Toyonaka, Osaka, 560-0083, Japan

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Asaka, Saitama, 3510021, Japan

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Gyōda, Saitama, 361-0056, Japan

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Iruma-gun, Saitama, 3500495, Japan

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Kitamoto, Saitama, 364-8501, Japan

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Sōka, Saitama, 340-0043, Japan

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Tokorozawa, Saitama, 359-1142, Japan

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Nagahama, Shiga, 526-8580, Japan

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Izunokuni, Shizuoka, 410-2295, Japan

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Mooka, Tochigi, 321-4306, Japan

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Hachiōji, Tokyo, 192-0918, Japan

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Machida, Tokyo, 194-0021, Japan

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Meguro City, Tokyo, 153-8515, Japan

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Minato, Tokyo, 106-0031, Japan

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Nerima-ku, Tokyo, 176-8530, Japan

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Shinjuku, Tokyo, 160-8488, Japan

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Shinjuku Ku, Tokyo, 1628666, Japan

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Sumida City, Tokyo, 130-8575, Japan

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Toshima-ku, Tokyo, 171-0014, Japan

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Novartis Investigative Site

Takaoka, Toyama, 939-1104, Japan

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Hashimoto, Wakayama, 648-0005, Japan

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Sakata, Yamagata, 998-8501, Japan

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Akita, 0108577, Japan

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Chiba, 261-0024, Japan

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Fukuoka, 811-0213, Japan

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Fukushima, 9601295, Japan

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Himeji, 671-1227, Japan

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Ishikawa, 9208641, Japan

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Novartis Investigative Site

Kagoshima, 892-0853, Japan

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Kumamoto, 861-4193, Japan

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Kyoto, 6078062, Japan

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Novartis Investigative Site

Nara, 630-8581, Japan

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Novartis Investigative Site

Okayama, 7008558, Japan

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Novartis Investigative Site

Osaka, 543-8555, Japan

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Novartis Investigative Site

Osaka, 5458586, Japan

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Novartis Investigative Site

Osaka, 558-8558, Japan

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Novartis Investigative Site

Shizuoka, 422-8527, Japan

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Hypercholesterolemia; Homozygous Familial Hypercholesterolemia

Interventions

ALN-PCS

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 23, 2024
• Study Start: March 4, 2024
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): December 17, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (106)