Last Update: Aug 09, 2024
Specified Drug-use Survey of Leqvio for s.c. Injection (Familial Hypercholesterolaemia or Hypercholesterolaemia, CKJX839A11401)
ClinicalTrials.gov Identifier:
NCT06275724
Novartis Reference Number:CKJX839A11401
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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 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.

Familial Hypercholesterolaemia, Hypercholesterolaemia
Recruiting
560
Mar 04, 2024
Dec 31, 2027
All
15 Years - (Child, Adult, Older Adult)

Interventions

Other

inclisiran

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

Eligibility Criteria

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.

Novartis Investigative Site

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Fukuoka city,Fukuoka,814 0180,Japan

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Omura,Nagasaki,856-8562,Japan

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Minato,Tokyo,106-0031,Japan

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Kobe,Hyogo,654-0026,Japan

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Osaka-city,Osaka,540-0006,Japan

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Fukushima,960-8611,Japan

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Yokosuka,Kanagawa,240-0101,Japan

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Ohtsu-city,Shiga,520-0046,Japan

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Toyoake city,Aichi,470 1192,Japan

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Osaka,543-0035,Japan

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Asahikawa,Hokkaido,078-8214,Japan

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Kurashiki,Okayama,713-8121,Japan

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Sakata-city,Yamagata,998-8501,Japan

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Tsukuba,Ibaraki,305-8576,Japan

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Gyoda,Saitama,361-0056,Japan

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Handa,Aichi,475-0817,Japan

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Kyoto,607-8062,Japan

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Ikoma,Nara,636-0802,Japan

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Nerima-ku,Tokyo,176-8530,Japan

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Kitakyushu,Fukuoka,800-0031,Japan

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Ono,Hyogo,675-1327,Japan

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Osaka-city,Osaka,543-8555,Japan

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Gifu,500-8384,Japan

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Yatsushiro-city,Kumamoto,866-8533,Japan

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Izunokuni,Shizuoka,410-2295,Japan

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Tsushima,Aichi,496-0038,Japan

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Osaka,545-8586,Japan

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Okayama-city,Okayama,700-8558,Japan

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Akita,010-8577,Japan

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Sapporo,Hokkaido,004-0052,Japan

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Kanazawa,Ishikawa,920 8641,Japan

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Iruma-gun,Saitama,350-0495,Japan

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Ichinomiya,Aichi,491-8551,Japan

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Kyoto,612-8555,Japan

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Kashihara,Nara,634-0045,Japan

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Shinjuku ku,Tokyo,162 8666,Japan

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Kitakyushu,Fukuoka,807-8556,Japan

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Himeji-city,671-1227,Japan

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Takarazuka-city,Hyogo,665-0873,Japan

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Takatsuki city,Osaka,569-0852,Japan

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Kyotanabe,Kyoto,610-0334,Japan

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Mooka,Tochigi,321-4306,Japan

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Asahi,Chiba,289-2511,Japan

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Osaka,558-8558,Japan

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Urasoe,Okinawa,901-2102,Japan

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Chiba,261-0024,Japan

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Sapporo,Hokkaido,062-0003,Japan

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Nagasaki,850-8555,Japan

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Fujisawa,Kanagawa,252-0802,Japan

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Kitamoto-city,Saitama,364-8501,Japan

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Ichinomiya,Aichi,494-0001,Japan

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Nara-city,Nara,630-8581,Japan

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Shinjuku,Tokyo,160-8488,Japan

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Fukushima city,Fukushima,960 1295,Japan

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Hiroshima,7320053,Japan

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Kamisu,Ibaraki,314-0146,Japan

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Takatsuki,Osaka,569-1121,Japan

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Yamagata,990 9585,Japan

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Kyoto-city,Kyoto,602-8566,Japan

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Hachioji,Tokyo,192-0918,Japan

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Inzai City,Chiba,270-1694,Japan

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Uruma,Okinawa,904-2293,Japan

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Fukui,910-8526,Japan

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Sapporo,Hokkaido,065-0027,Japan

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Komaki,Aichi,485-8520,Japan

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Nagasaki,852-8055,Japan

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Yokohama,Kanagawa,227-8501,Japan

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Soka,Saitama,340-0043,Japan

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Nagaoka,Niigata,940-8621,Japan

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Toshima-ku,Tokyo,171-0014,Japan

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Koriyama,Fukushima,963-8501,Japan

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Kagoshima,890-8760,Japan

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Koga,Ibaraki,306-0232,Japan

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Takatsuki,Osaka,569-8686,Japan

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Urayasu,Chiba,279-0021,Japan

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Miyakonojo,Miyazaki,885-0002,Japan

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Machida,Tokyo,194-0021,Japan

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Izumisano-city,Osaka,598-8577,Japan

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Fukuoka,811-0213,Japan

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Amagasaki,Hyogo,660-8511,Japan

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Nagoya,Aichi,454-0933,Japan

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Oita,870-1133,Japan

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Yokohama,Kanagawa,235-0016,Japan

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Tokorozawa,Saitama,359-1142,Japan

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Shirakawa,Fukushima,961-0005,Japan

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Oita-city,Oita,870-0263,Japan

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Takaoka,Toyama,939-1104,Japan

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Kagoshima,892-0853,Japan

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Mito,Ibaraki,310-0015,Japan

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Toyonaka,Osaka,560-0083,Japan

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Matsuyama,Ehime,791-8016,Japan

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Matsumoto,Nagano,390-8505,Japan

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Meguro,Tokyo,153-8515,Japan

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Himeji,Hyogo,670-8560,Japan

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Moriguchi,Osaka,570-8507,Japan

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Kadoma,Osaka,571-0027,Japan

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Fukuoka,815-0082,Japan

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Nagoya,Aichi,461-0045,Japan

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Oita,879-7761,Japan

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Yokosuka,Kanagawa,238-8567,Japan

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Nagahama,Shiga,526-8580,Japan

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Kure-city,Hiroshima,737-0023,Japan

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Kurashiki,Okayama,710-8602,Japan

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Hashimoto,Wakayama,648-0005,Japan

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Moriya-city,Ibaraki,302-0102,Japan

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Asaka,Saitama,3510021,Japan

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Kumamoto,861-4193,Japan

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