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Active (not recruiting) NCT06275724

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

Conditions: Familial Hypercholesterolaemia Hypercholesterolaemia

Sponsor: Novartis Pharmaceuticals

trial.available_in: БГ
Overview
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
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.
Who can participate
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.
Interventions
inclisiran
OTHER
Locations 106
Japan (106)
Novartis Investigative Site
Akita
Novartis Investigative Site
Amagasaki , Hyōgo
Novartis Investigative Site
Asahi , Chiba
Novartis Investigative Site
Asahikawa , Hokkaido
Novartis Investigative Site
Asahikawa , Hokkaido
Novartis Investigative Site
Asaka , Saitama
Novartis Investigative Site
Chiba
Novartis Investigative Site
Fujisawa , Kanagawa
Novartis Investigative Site
Fukui-shi , Fukui
Novartis Investigative Site
Fukuoka
Novartis Investigative Site
Fukuoka , Fukuoka
Novartis Investigative Site
Fukuoka , Fukuoka
Novartis Investigative Site
Fukushima
Novartis Investigative Site
Fukushima , Fukushima
Novartis Investigative Site
Gifu , Gifu
Novartis Investigative Site
Gyōda , Saitama
Novartis Investigative Site
Hachiōji , Tokyo
Novartis Investigative Site
Handa , Aichi-ken
Novartis Investigative Site
Hashimoto , Wakayama
Novartis Investigative Site
Himeji
Novartis Investigative Site
Himeji , Hyōgo
Novartis Investigative Site
Hiroshima , Hiroshima
Novartis Investigative Site
Ichinomiya , Aichi-ken
Novartis Investigative Site
Ichinomiya , Aichi-ken
Novartis Investigative Site
Ikoma , Nara
Novartis Investigative Site
Inzai , Chiba
Novartis Investigative Site
Iruma-gun , Saitama
Novartis Investigative Site
Ishikawa
Novartis Investigative Site
Izumisano , Osaka
Novartis Investigative Site
Izunokuni , Shizuoka
Novartis Investigative Site
Kagoshima
Novartis Investigative Site
Kagoshima , Kagoshima-ken
Novartis Investigative Site
Kamisu , Ibaraki
Novartis Investigative Site
Kashihara , Nara
Novartis Investigative Site
Kitakyushu , Fukuoka
Novartis Investigative Site
Kitakyushu , Fukuoka
Novartis Investigative Site
Kitamoto , Saitama
Novartis Investigative Site
Kobe , Hyōgo
Novartis Investigative Site
Koga , Ibaraki
Novartis Investigative Site
Komaki , Aichi-ken
Novartis Investigative Site
Kōriyama , Fukushima
Novartis Investigative Site
Kumamoto
Novartis Investigative Site
Kurashiki , Okayama-ken
Novartis Investigative Site
Kure , Hiroshima
Novartis Investigative Site
Kyōtanabe , Kyoto
Novartis Investigative Site
Kyoto , Kyoto
Novartis Investigative Site
Kyoto , Kyoto
Novartis Investigative Site
Kyoto
Novartis Investigative Site
Machida , Tokyo
Novartis Investigative Site
Matsuyama , Ehime
Novartis Investigative Site
Meguro City , Tokyo
Novartis Investigative Site
Minato , Tokyo
Novartis Investigative Site
Mito , Ibaraki
Novartis Investigative Site
Mooka , Tochigi
Novartis Investigative Site
Moriguchi , Osaka
Novartis Investigative Site
Moriya , Ibaraki
Novartis Investigative Site
Nagahama , Shiga
Novartis Investigative Site
Nagaoka , Niigata
Novartis Investigative Site
Nagasaki , Nagasaki
Novartis Investigative Site
Nagasaki , Nagasaki
Novartis Investigative Site
Nagoya , Aichi-ken
Novartis Investigative Site
Nagoya , Aichi-ken
Novartis Investigative Site
Nara
Novartis Investigative Site
Nerima-ku , Tokyo
Novartis Investigative Site
Ōita , Oita Prefecture
Novartis Investigative Site
Ōita , Oita Prefecture
Novartis Investigative Site
Ōita , Oita Prefecture
Novartis Investigative Site
Okayama
Novartis Investigative Site
Ōmura , Nagasaki
Novartis Investigative Site
Ono , Hyōgo
Novartis Investigative Site
Osaka , Osaka
Novartis Investigative Site
Osaka , Osaka
Novartis Investigative Site
Osaka
Novartis Investigative Site
Osaka
Novartis Investigative Site
Osaka
Novartis Investigative Site
Sakata , Yamagata
Novartis Investigative Site
Sapporo , Hokkaido
Novartis Investigative Site
Sapporo , Hokkaido
Novartis Investigative Site
Sapporo , Hokkaido
Novartis Investigative Site
Shinjuku , Tokyo
Novartis Investigative Site
Shinjuku Ku , Tokyo
Novartis Investigative Site
Shirakawa , Fukushima
Novartis Investigative Site
Shizuoka
Novartis Investigative Site
Sōka , Saitama
Novartis Investigative Site
Sumida City , Tokyo
Novartis Investigative Site
Takaoka , Toyama
Novartis Investigative Site
Takarazuka , Hyōgo
Novartis Investigative Site
Takatsuki , Osaka
Novartis Investigative Site
Takatsuki , Osaka
Novartis Investigative Site
Takatsuki , Osaka
Novartis Investigative Site
Tenri , Nara
Novartis Investigative Site
Tokorozawa , Saitama
Novartis Investigative Site
Toshima-ku , Tokyo
Novartis Investigative Site
Toyoake , Aichi-ken
Novartis Investigative Site
Toyonaka , Osaka
Novartis Investigative Site
Tsu , Mie-ken
Novartis Investigative Site
Tsukuba , Ibaraki
Novartis Investigative Site
Tsushima , Aichi-ken
Novartis Investigative Site
Urasoe , Okinawa
Novartis Investigative Site
Urayasu , Chiba
Novartis Investigative Site
Uruma , Okinawa
Novartis Investigative Site
Yatsushiro , Kumamoto
Novartis Investigative Site
Yokohama , Kanagawa
Novartis Investigative Site
Yokohama , Kanagawa
Novartis Investigative Site
Yokosuka , Kanagawa
Novartis Investigative Site
Yokosuka , Kanagawa
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
15 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
04.03.2024
Completion date
17.12.2026
Registry ID
NCT06275724
Source
clinicaltrials.gov
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