Pelacarsen Roll-over Extension Program
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pelacarsen (TQJ230)
Treatment groups
599 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov