The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy
Status:
Terminated
Trial end date:
2019-11-13
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52
weeks in a randomized treatment (RT) period in participants with familial partial
lipodystrophy (FPL). Following the randomized treatment period, participants who did not
enter the open-label extension (OLE) period went straight to the 13-week post-treatment (PT)
follow-up period and participants who were entered in the OLE period continued to receive
volanesorsen for another 52 weeks (Weeks 53 to 104). Following the Week 104 visit of the OLE
period, participants had an option of continued dosing for up to an additional 52 weeks (Week
105 to 156). Participants who did not enter the OLE period went straight to a 13-week
post-treatment follow-up period. Following the Week 104 OLE period, participants were entered
a 13-week post-treatment follow-up period, if they did not choose the option for continued
dosing.