Pelacarsen Roll-over Extension Program
Purpose
This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).
Condition
- Atherosclerotic Cardiovascular Disease
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants who have provided informed consent prior to initiation of any study-specific activities/procedures. - Participants who have completed the parent study and received the assigned study treatment at the time of its completion
Exclusion Criteria
- Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study - Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation - Participants who are receiving another investigational drug or device before the open-label treatment period - Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Rollover extension program (REP)
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- Open label study
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Pelacarsen (TQJ230) |
open-label pelacarsen 80mg |
|
Recruiting Locations
University of Texas Health Science Ctr
San Antonio 4726206, Texas 4736286 78229-3900
San Antonio 4726206, Texas 4736286 78229-3900
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Detailed Description
This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.