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Clinical Trials List

Protocol NumberCTQJ230A12301E1
Not yet recruiting

2025-06-02 - 2029-12-31

Phase III

Recruiting9

ICD-10I25.10

Atherosclerotic heart disease of native coronary artery without angina pectoris

ICD-9429.2

Cardiovascular disease, unspecified

A single-arm, multicenter, open-label extension (OLE) trial was conducted to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in participants completing the main trial of Lp(a)HORIZON.

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    Novartis Taiwan Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/27

Investigators and Locations

Principal Investigator Shih-Hsien Sung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 曹玄明

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉銘恩

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 施志遠

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 翁國昌

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳韋翔

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭正一

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-Chang Hsieh

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Diagnosed cardiovascular disease (CVD) and elevated lipoprotein (Lp(a))

Objectives

The purpose of this study was to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in participants who had completed the main trial of Lp(a)HORIZON (CTQJ230A12301).

Test Drug

TQJ230

Active Ingredient

Pelacarsen

Dosage Form

Prefilled Injectable

Dosage

80 mg/0.8 mL

Endpoints

Incidence of the following events:

• Treatment-induced adverse events (TEAEs)

• Serious treatment-induced adverse events (TESAEs)

• Treatment discontinuation due to TEAE/TESAE

• TEAEs of particular concern

Observations or changes/variations from the baseline period for the following items:

• Laboratory safety assessments

• Vital signs

Inclution Criteria

1. Participants who have signed a participant consent form before commencing any trial-specific activities/procedures.

2. Participants who are still receiving the designated investigational drug at their end-of-study (EOS) follow-up visit after completing the main trial.

Exclusion Criteria

1. Participants who, for any reason, permanently discontinue or interrupt the investigational drug for 6 months during the EOS phase of the main trial.

2. Participants with a history or evidence of clinically significant abnormalities, symptoms, or diseases that, as determined by the trial administrator or a Novartis physician (if consulted), would put the participant at risk or interfere with trial participation, including but not limited to the situations mentioned in Tables 6-3 and 6-5 of the program.

3. Participants who were receiving other investigational drugs or devices prior to the open-label treatment phase.

4. Women who are pregnant or breastfeeding.

5. Women of childbearing age, unless they are using highly effective contraception.

The Estimated Number of Participants

  • Taiwan

    68 participants

  • Global

    5700 participants