臨床研究等提出・公開システム

Japanese

Date of registration	April. 21, 2026
Last modified on	April. 21, 2026
Trial ID	jRCT2031260071

Scientific Title	A single arm, multicenter, open-label extension (OLE) trial to evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants who completed the parent Lp(a)HORIZON trial (CTQJ230A12301E1)
Public Title	An open-label extension (OLE) trial to evaluate long-term safety and tolerability of pelacarsen (TQJ230) (CTQJ230A12301E1)

Contact for Scientific Queries	Name	Maruyama Hideki
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku@novartis.com
Contact for Public Queries	Name	Maruyama Hideki
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku@novartis.com

Recruitment status	Pending

Anticipated date of first enrollment		May. 11, 2026
Target sample size		100
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Participants who have provided informed consent prior to initiation of any study-specific activities/procedures. - Participants who have completed the parent study EOS visit while still on assigned investigational product.
	Exclusion Criteria	- Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study. - Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation. - Participants are receiving another investigational drug or device before the open-label treatment period. - Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.
	Age Minimum	18age old over
	Age Maximum	100age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		patients with established cardiovascular disease and elevated Lp(a)
Intervention(s)		pelacarsen 80mg s.c. monthly
Primary Outcome(s)		Number of participants with Adverse events

Primary Sponsor	Novartis Pharma. K.K.

Secondary Sponsor

Name of Certified Review Board	IRB of Tokyo Eki Center building Clinic
Address	3-3-14, Nihonbashi, Chuo-ku, Tokyo
Telephone	+81-3-3243-0138
E-Mail	info_tecc-irb@tec-c.jp
Approval Status	Approval
Date of approval	May. 09, 2025

Plan to share IPD	Yes
Plan description	Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Plan to share IPD

Yes

Plan description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Secondary ID(s)	NCT07517263
Issuing Authority	Clinical Trials.gov

Countries of Recruitment（Except Japan）	United States/Argentina/Belgium/Brazil/Colombia/Czechia/Germany/India/Israel/Italy/Netherlands/Romania/Slovakia/Spain/Switzerland/Turkey/United Kingdom