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NCT03759379 · ClinicalTrials.gov registry record · Phase 3
HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)
A Phase 3 study, sponsored by Alnylam Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 164
- Enrollment target
NCT03759379 is a Phase 3 study that has completed, run by Alnylam Pharmaceuticals. The registered enrollment target is 164 participants.
The verdict
NCT03759379, a Phase 3 study, has completed, sponsored by Alnylam Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 164 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of vutrisiran (ALN-TTRSC02) in participants with hereditary transthyretin amyloidosis (hATTR amyloidosis). Participants will receive vutrisiran subcutaneous (SC) injection once every 3 months (q3M) or the reference comparator patisiran intravenous (IV) injection once every 3 weeks (q3w) during the 18 month Treatment Period. This study will use the placebo arm of the APOLLO study (NCT01960348) as an external comparator for the primary and most other efficacy endpoints during the 18 Month Treatment Period. Following the 18 Month Treatment Period, all participants will be randomized to receive vutrisiran 50 mg SC injection once every 6 months (q6M) or vutrisiran 25 mg q3M in the Randomized Treatment Extension (RTE) Period. Upon implementation of Amendment 6, participants receiving vutrisiran SC 50 mg q6M will transition to vutrisiran SC 25 mg q3M at their next scheduled dosing.
Interventions
- DRUG Vutrisiran
- DRUG Patisiran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2019-02-14 |
| Est. Completion | 2025-11-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03759379
The ClinicalTrials.gov registry entry for NCT03759379 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alnylam Pharmaceuticals, which has 49 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vutrisiran is the first listed.
NCT03759379 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03759379 about?
NCT03759379 is a clinical study titled "HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)". The purpose of this study is to evaluate the efficacy and safety of vutrisiran (ALN-TTRSC02) in participants with hereditary transthyretin amyloidosis (hATTR amyloidosis). Participants will receive vutrisiran subcutaneous (SC) injection once every 3 months (q3M) or the reference comparator patisiran...
What is the current status of trial NCT03759379?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 164 participants. The study started on 2019-02-14. Estimated completion is 2025-11-05.
What interventions are being tested in trial NCT03759379?
The interventions under investigation include: Vutrisiran (DRUG), Patisiran (DRUG).
Who is sponsoring clinical trial NCT03759379?
This trial is sponsored by Alnylam Pharmaceuticals, which has 49 total clinical trials registered on ClinicalTrials.gov.
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