Last Update: Mar 15, 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.

Study Location

Novartis Investigative Site

Recruiting

Machida,Tokyo,194-0021,Japan

Novartis Investigative Site

Recruiting

Toshima-ku,Tokyo,171-0014,Japan

Novartis Investigative Site

Recruiting

Ikoma,Nara,636-0802,Japan

Novartis Investigative Site

Recruiting

Osaka,545-8586,Japan

Novartis Investigative Site

Recruiting

Matsuyama,Ehime,791-8016,Japan

Novartis Investigative Site

Recruiting

Toyonaka,Osaka,560-0083,Japan

Novartis Investigative Site

Recruiting

Kanazawa-city,Ishikawa,920-8641,Japan

Novartis Investigative Site

Recruiting

Sapporo,Hokkaido,004-0052,Japan

Novartis Investigative Site

Recruiting

Nagasaki,852-8055,Japan

Novartis Investigative Site

Recruiting

Urasoe,Okinawa,901-2102,Japan

Novartis Investigative Site

Recruiting

Kashihara,Nara,634-0045,Japan

Novartis Investigative Site

Recruiting

Takaoka,Toyama,939-1104,Japan

Novartis Investigative Site

Recruiting

Nerima-ku,Tokyo,176-8530,Japan

Novartis Investigative Site

Recruiting

Yokohama,Kanagawa,235-0016,Japan

Novartis Investigative Site

Recruiting

Kitakyushu,Fukuoka,800-0031,Japan

Novartis Investigative Site

Recruiting

Takarazuka-city,Hyogo,665-0873,Japan

Novartis Investigative Site

Recruiting

Asahikawa,Hokkaido,078-8214,Japan

Novartis Investigative Site

Recruiting

Oita,870-1133,Japan

Novartis Investigative Site

Recruiting

Kobe,Hyogo,654-0026,Japan

Novartis Investigative Site

Recruiting

Takatsuki-city,Osaka,569-0852,Japan

Novartis Investigative Site

Recruiting

Fukuoka,815-0082,Japan

Novartis Investigative Site

Recruiting

Oita,879-7761,Japan

Novartis Investigative Site

Recruiting

Kurashiki,Okayama,713-8121,Japan

Novartis Investigative Site

Recruiting

Takatsuki-city,Osaka,569-8686,Japan

Novartis Investigative Site

Recruiting

Handa,Aichi,475-0817,Japan

Novartis Investigative Site

Recruiting

Osaka-city,Osaka,543-8555,Japan

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