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NCT06275724 Clinical Trial

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

Hypercholesterolaemia Clinical Trial

Official title:
Specified Drug-use Survey of Leqvio for s.c. Injection (Familial Hypercholesterolaemia or Hypercholesterolaemia, CKJX839A11401)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06275724
Other study ID # CKJX839A11401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 4, 2024
Est. completion date December 31, 2027

Study information
Verified date April 2024
Source Novartis
Contact Novartis Pharmaceuticals
Phone +81337978748
Email novartis.email@novartis.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 560
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Japan Novartis Investigative Site Amagasaki Hyogo
Japan Novartis Investigative Site Asahikawa Hokkaido
Japan Novartis Investigative Site Asaka Saitama
Japan Novartis Investigative Site Fujisawa Kanagawa
Japan Novartis Investigative Site Fukuoka
Japan Novartis Investigative Site Fukuoka-city Fukuoka
Japan Novartis Investigative Site Gifu
Japan Novartis Investigative Site Gyoda Saitama
Japan Novartis Investigative Site Hachioji-city Tokyo
Japan Novartis Investigative Site Handa Aichi
Japan Novartis Investigative Site Hashimoto Wakayama
Japan Novartis Investigative Site Himeji Hyogo
Japan Novartis Investigative Site Ichinomiya Aichi
Japan Novartis Investigative Site Ikoma Nara
Japan Novartis Investigative Site Izumisano-city Osaka
Japan Novartis Investigative Site Kagoshima
Japan Novartis Investigative Site Kanazawa-city Ishikawa
Japan Novartis Investigative Site Kashihara Nara
Japan Novartis Investigative Site Kitakyushu Fukuoka
Japan Novartis Investigative Site Kobe Hyogo
Japan Novartis Investigative Site Komaki Aichi
Japan Novartis Investigative Site Kumamoto-city Kumamoto
Japan Novartis Investigative Site Kurashiki Okayama
Japan Novartis Investigative Site Kure-city Hiroshima
Japan Novartis Investigative Site Kyotanabe Kyoto
Japan Novartis Investigative Site Kyoto-city Kyoto
Japan Novartis Investigative Site Kyoto-city Kyoto
Japan Novartis Investigative Site Machida Tokyo
Japan Novartis Investigative Site Matsuyama Ehime
Japan Novartis Investigative Site Moriguchi Osaka
Japan Novartis Investigative Site Moriya-city Ibaraki
Japan Novartis Investigative Site Nagahama Shiga
Japan Novartis Investigative Site Nagaoka-city Niigata
Japan Novartis Investigative Site Nagasaki
Japan Novartis Investigative Site Nagoya Aichi
Japan Novartis Investigative Site Nagoya Aichi
Japan Novartis Investigative Site Nerima-ku Tokyo
Japan Novartis Investigative Site Oita
Japan Novartis Investigative Site Oita
Japan Novartis Investigative Site Oita-city Oita
Japan Novartis Investigative Site Okayama-city Okayama
Japan Novartis Investigative Site Omura Nagasaki
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Osaka-city Osaka
Japan Novartis Investigative Site Osaka-city Osaka
Japan Novartis Investigative Site Osaka-city Osaka
Japan Novartis Investigative Site Sakata-city Yamagata
Japan Novartis Investigative Site Sapporo Hokkaido
Japan Novartis Investigative Site Sapporo Hokkaido
Japan Novartis Investigative Site Shinjuku Tokyo
Japan Novartis Investigative Site Shirakawa Fukushima
Japan Novartis Investigative Site Takaoka Toyama
Japan Novartis Investigative Site Takarazuka-city Hyogo
Japan Novartis Investigative Site Takatsuki Osaka
Japan Novartis Investigative Site Takatsuki-city Osaka
Japan Novartis Investigative Site Takatsuki-city Osaka
Japan Novartis Investigative Site Tokorozawa Saitama
Japan Novartis Investigative Site Toshima-ku Tokyo
Japan Novartis Investigative Site Toyoake city Aichi
Japan Novartis Investigative Site Toyonaka Osaka
Japan Novartis Investigative Site Urasoe Okinawa
Japan Novartis Investigative Site Uruma Okinawa
Japan Novartis Investigative Site Yatsushiro-city Kumamoto
Japan Novartis Investigative Site Yokohama Kanagawa
Japan Novartis Investigative Site Yokosuka Kanagawa
Japan Novartis Investigative Site Yokosuka Kanagawa

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with adverse events To evaluate the long-term safety profile of Leqvio Up to 24 months
Primary 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 Number of patients with adverse events leading to discontinuation of treatment with the product To evaluate the tolerability of Leqvio Up to 24 months
Secondary Percent change from baseline in LDL-C levels To evaluate the efficacy of Leqvio based on LDL-C levels Month 24
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