Clinical trial NCT06275724: Specified Drug-use Survey of Leqvio for s.c. Injection.
Official title: Specified Drug-use Survey of Leqvio for s.c. Injection (Familial Hypercholesterolaemia or Hypercholesterolaemia, CKJX839A11401)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Familial Hypercholesterolaemia
Hypercholesterolaemia
Keywords: familial hypercholesterolaemia
hypercholesterolaemia
FH
HoFH
Leqvio
inclisiran sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-02-23
Enrollment: 583
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with inclisiran

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

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.

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.

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: Up to 24 months
measure: Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions
timeFrame: Up to 24 months
Secondary outcomes:
measure: Number of patients with adverse events leading to discontinuation of treatment with the product
timeFrame: Up to 24 months
measure: Percent change from baseline in LDL-C levels
timeFrame: Month 24
Other outcomes:
Locations:
city: Handa
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Ichinomiya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Ichinomiya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Komaki
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyoake city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Tsushima
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Asahi
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Inzai City
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Urayasu
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fukushima city
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Koriyama
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Shirakawa
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Kure-city
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Asahikawa
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Asahikawa
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Amagasaki
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Himeji
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Ono
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Takarazuka-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kamisu
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Koga
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Mito
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Moriya-city
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Tsukuba
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Fujisawa
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokosuka
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokosuka
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yatsushiro-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kyotanabe
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Tsu-city
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Omura
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Ikoma
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Kashihara
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Tenri
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Nagaoka
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Oita-city
country: Japan
facility: Novartis Investigative Site
state: Oita
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Urasoe
country: Japan
facility: Novartis Investigative Site
state: Okinawa
city: Uruma
country: Japan
facility: Novartis Investigative Site
state: Okinawa
city: Izumisano-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Moriguchi
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Takatsuki city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Takatsuki
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Takatsuki
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Toyonaka
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Asaka
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Gyoda
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Iruma-gun
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kitamoto-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Soka
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokorozawa
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Nagahama
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Izunokuni
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Mooka
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Hachioji
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Machida
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Meguro
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Nerima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Sumida
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Takaoka
country: Japan
facility: Novartis Investigative Site
state: Toyama
city: Hashimoto
country: Japan
facility: Novartis Investigative Site
state: Wakayama
city: Sakata-city
country: Japan
facility: Novartis Investigative Site
state: Yamagata
city: Akita
country: Japan
facility: Novartis Investigative Site
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Fukui
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukushima
country: Japan
facility: Novartis Investigative Site
city: Gifu
country: Japan
facility: Novartis Investigative Site
city: Himeji-city
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Kagoshima
country: Japan
facility: Novartis Investigative Site
city: Kagoshima
country: Japan
facility: Novartis Investigative Site
city: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Nagasaki
country: Japan
facility: Novartis Investigative Site
city: Nagasaki
country: Japan
facility: Novartis Investigative Site
city: Nara
country: Japan
facility: Novartis Investigative Site
city: Oita
country: Japan
facility: Novartis Investigative Site
city: Oita
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Shizuoka
country: Japan
facility: Novartis Investigative Site
city: Yamagata
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: