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NCT02527343 · ClinicalTrials.gov registry record · Phase 2
The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy
A Phase 2 study, sponsored by Akcea Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT02527343 is a Phase 2 study that was terminated before completion, run by Akcea Therapeutics. The registered enrollment target is 40 participants.
The verdict
NCT02527343, a Phase 2 study, was terminated before completion, sponsored by Akcea Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG volanesorsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-12-28 |
| Est. Completion | 2019-11-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02527343
The ClinicalTrials.gov registry entry for NCT02527343 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akcea Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02527343 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02527343 about?
NCT02527343 is a clinical study titled "The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy". 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...
What is the current status of trial NCT02527343?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2015-12-28. Estimated completion is 2019-11-13.
What interventions are being tested in trial NCT02527343?
The interventions under investigation include: Placebo (DRUG), volanesorsen (DRUG).
Who is sponsoring clinical trial NCT02527343?
This trial is sponsored by Akcea Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
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