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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hypercholesterolaemia; Familial Hypercholesterolaemia
• Intervention / Treatment: Other: inclisiran

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.

• Study Type: Observational
• Enrollment (Estimated): 560

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +81337978748; Email: novartis.email@novartis.com

Study Locations

• Japan
  • Fukuoka, Japan, 815-0082
    • Recruiting
    • Novartis Investigative Site
  • Gifu, Japan, 500-8384
    • Recruiting
    • Novartis Investigative Site
  • Kagoshima, Japan, 892-0853
    • Recruiting
    • Novartis Investigative Site
  • Nagasaki, Japan, 852-8055
    • Recruiting
    • Novartis Investigative Site
  • Oita, Japan, 870-1133
    • Recruiting
    • Novartis Investigative Site
  • Oita, Japan, 879-7761
    • Recruiting
    • Novartis Investigative Site
  • Osaka, Japan, 545-8586
    • Recruiting
    • Novartis Investigative Site
  • Aichi
    • Handa, Aichi, Japan, 475-0817
      • Recruiting
      • Novartis Investigative Site
    • Ichinomiya, Aichi, Japan, 491-8551
      • Recruiting
      • Novartis Investigative Site
    • Komaki, Aichi, Japan, 485-8520
      • Recruiting
      • Novartis Investigative Site
    • Nagoya, Aichi, Japan, 461-0045
      • Recruiting
      • Novartis Investigative Site
    • Nagoya, Aichi, Japan, 454-0933
      • Recruiting
      • Novartis Investigative Site
    • Toyoake city, Aichi, Japan, 470 1192
      • Recruiting
      • Novartis Investigative Site
  • Ehime
    • Matsuyama, Ehime, Japan, 791-8016
      • Recruiting
      • Novartis Investigative Site
  • Fukuoka
    • Fukuoka-city, Fukuoka, Japan, 811-0213
      • Recruiting
      • Novartis Investigative Site
    • Kitakyushu, Fukuoka, Japan, 800-0031
      • Recruiting
      • Novartis Investigative Site
  • Fukushima
    • Shirakawa, Fukushima, Japan, 961-0005
      • Recruiting
      • Novartis Investigative Site
  • Hiroshima
    • Kure-city, Hiroshima, Japan, 737-0023
      • Recruiting
      • Novartis Investigative Site
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 078-8214
      • Recruiting
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 004-0052
      • Recruiting
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 065-0027
      • Recruiting
      • Novartis Investigative Site
  • Hyogo
    • Amagasaki, Hyogo, Japan, 660-8511
      • Recruiting
      • Novartis Investigative Site
    • Himeji, Hyogo, Japan, 670-8560
      • Recruiting
      • Novartis Investigative Site
    • Kobe, Hyogo, Japan, 654-0026
      • Recruiting
      • Novartis Investigative Site
    • Takarazuka-city, Hyogo, Japan, 665-0873
      • Recruiting
      • Novartis Investigative Site
  • Ibaraki
    • Moriya-city, Ibaraki, Japan, 302-0102
      • Recruiting
      • Novartis Investigative Site
  • Ishikawa
    • Kanazawa-city, Ishikawa, Japan, 920-8641
      • Recruiting
      • Novartis Investigative Site
  • Kanagawa
    • Fujisawa, Kanagawa, Japan, 252-0802
      • Recruiting
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 235-0016
      • Recruiting
      • Novartis Investigative Site
    • Yokosuka, Kanagawa, Japan, 238-8567
      • Recruiting
      • Novartis Investigative Site
    • Yokosuka, Kanagawa, Japan, 240-0101
      • Recruiting
      • Novartis Investigative Site
  • Kumamoto
    • Kumamoto-city, Kumamoto, Japan, 861-4193
      • Recruiting
      • Novartis Investigative Site
    • Yatsushiro-city, Kumamoto, Japan, 866-8533
      • Recruiting
      • Novartis Investigative Site
  • Kyoto
    • Kyotanabe, Kyoto, Japan, 610-0334
      • Recruiting
      • Novartis Investigative Site
    • Kyoto-city, Kyoto, Japan, 602-8566
      • Recruiting
      • Novartis Investigative Site
    • Kyoto-city, Kyoto, Japan, 607-8062
      • Recruiting
      • Novartis Investigative Site
  • Nagasaki
    • Omura, Nagasaki, Japan, 856-8562
      • Recruiting
      • Novartis Investigative Site
  • Nara
    • Ikoma, Nara, Japan, 636-0802
      • Recruiting
      • Novartis Investigative Site
    • Kashihara, Nara, Japan, 634-0045
      • Recruiting
      • Novartis Investigative Site
  • Niigata
    • Nagaoka-city, Niigata, Japan, 940-8621
      • Recruiting
      • Novartis Investigative Site
  • Oita
    • Oita-city, Oita, Japan, 870-0263
      • Recruiting
      • Novartis Investigative Site
  • Okayama
    • Kurashiki, Okayama, Japan, 713-8121
      • Recruiting
      • Novartis Investigative Site
    • Okayama-city, Okayama, Japan, 700-8558
      • Recruiting
      • Novartis Investigative Site
  • Okinawa
    • Urasoe, Okinawa, Japan, 901-2102
      • Recruiting
      • Novartis Investigative Site
    • Uruma, Okinawa, Japan, 904-2293
      • Recruiting
      • Novartis Investigative Site
  • Osaka
    • Izumisano-city, Osaka, Japan, 598-8577
      • Recruiting
      • Novartis Investigative Site
    • Moriguchi, Osaka, Japan, 570-8507
      • Recruiting
      • Novartis Investigative Site
    • Osaka-city, Osaka, Japan, 543-8555
      • Recruiting
      • Novartis Investigative Site
    • Osaka-city, Osaka, Japan, 540-0006
      • Recruiting
      • Novartis Investigative Site
    • Osaka-city, Osaka, Japan, 543-0035
      • Recruiting
      • Novartis Investigative Site
    • Takatsuki, Osaka, Japan, 569-1121
      • Recruiting
      • Novartis Investigative Site
    • Takatsuki-city, Osaka, Japan, 569-8686
      • Recruiting
      • Novartis Investigative Site
    • Takatsuki-city, Osaka, Japan, 569-0852
      • Recruiting
      • Novartis Investigative Site
    • Toyonaka, Osaka, Japan, 560-0083
      • Recruiting
      • Novartis Investigative Site
  • Saitama
    • Asaka, Saitama, Japan, 351-0021
      • Recruiting
      • Novartis Investigative Site
    • Gyoda, Saitama, Japan, 361-0056
      • Recruiting
      • Novartis Investigative Site
    • Tokorozawa, Saitama, Japan, 359-1142
      • Recruiting
      • Novartis Investigative Site
  • Shiga
    • Nagahama, Shiga, Japan, 526-8580
      • Recruiting
      • Novartis Investigative Site
  • Tokyo
    • Hachioji-city, Tokyo, Japan, 192-0918
      • Recruiting
      • Novartis Investigative Site
    • Machida, Tokyo, Japan, 194-0021
      • Recruiting
      • Novartis Investigative Site
    • Nerima-ku, Tokyo, Japan, 176-8530
      • Recruiting
      • Novartis Investigative Site
    • Shinjuku, Tokyo, Japan, 160-8488
      • Recruiting
      • Novartis Investigative Site
    • Toshima-ku, Tokyo, Japan, 171-0014
      • Recruiting
      • Novartis Investigative Site
  • Toyama
    • Takaoka, Toyama, Japan, 939-1104
      • Recruiting
      • Novartis Investigative Site
  • Wakayama
    • Hashimoto, Wakayama, Japan, 648-0005
      • Recruiting
      • Novartis Investigative Site
  • Yamagata
    • Sakata-city, Yamagata, Japan, 998-8501
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with inclisiran

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
inclisiran; Patients prescribed with inclisiran	Other: inclisiran; Prospective observational study. There is no treatment allocation. Patients prescribed with inclisiran are eligible to enroll into this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events	To evaluate the long-term safety profile of Leqvio	Up to 24 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events leading to discontinuation of treatment with the product	To evaluate the tolerability of Leqvio	Up to 24 months
Percent change from baseline in LDL-C levels	To evaluate the efficacy of Leqvio based on LDL-C levels	Month 24

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: familial hypercholesterolaemia; FH; hypercholesterolaemia; HoFH; Leqvio; inclisiran sodium
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Hypercholesterolemia; Hyperlipoproteinemia Type II
• Other Study ID Numbers: CKJX839A11401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO