Pelacarsen Roll-over Extension Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pelacarsen (TQJ230).
- Who it may be relevant to
- Registry conditions: Atherosclerotic Cardiovascular Disease. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open-Label Pelacarsen in Participants With Elevated Lp(a) and Established ASCVD
Overview
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).
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.
Interventions
- Drug Pelacarsen (TQJ230)
pelacarsen 80mg s.c. monthly
Primary outcome measures
- Incidence of Adverse events (AEs) or serious adverse events (SAEs) [Time frame: Up to 48 months]
Secondary outcome measures (2)
- Observed value and change in Lipoprotein(a) (Lp(a)) compared to baseline of the parent study [Time frame: Baseline of the core study, Month 3, 12, 24, 36, 48]
- Observed value and change in Lp(a) compared to baseline of the rollover extension program (REP) study [Time frame: Baseline of the REP study, Month 3, 12, 24, 36, 48]
Eligibility 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 91 centers
- Parkway Medical Center — Birmingham
- Cardiology and Medicine Clinic PA — Little Rock
- National Heart Institute — Beverly Hills
- Hope Clinical Research — Canoga Park
- Valley Clinical Trials Inc — Covina
- NICRs Research Center — Garden Grove
- University of Calif Irvine Med Cntr — Irvine
- Long Beach Clinical Trials — Long Beach
- … and 83 more centers
Puerto Rico · 6 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06875973 · CTQJ230A12305B