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NCT01960348 · ClinicalTrials.gov registry record · Phase 3
APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis
A Phase 3 study, sponsored by Alnylam Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
NCT01960348: Completed Phase 3 study, sponsored by Alnylam Pharmaceuticals.
NCT01960348 is a Phase 3 study that has completed, run by Alnylam Pharmaceuticals. The registered enrollment target is 225 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01960348, a Phase 3 study, has completed, sponsored by Alnylam Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.
Primary Outcome
The difference between the patisiran (ALN-TTR02) and placebo groups in the change from baseline in mNIS+7 at 18 months. The mNIS+7 is a composite score that quantitates motor, sensory, and autonomic neurologic impairment due to injury of large and small nerves. The minimum and maximum values are 0 and 304, respectively. A higher score indicates a worse outcome.
Interventions
- DRUG Sterile Normal Saline (0.9% NaCl)
- DRUG patisiran (ALN-TTR02)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-08 |
| Phase | Phase 3 |
What the finished NCT01960348 record still lists
NCT01960348 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Sterile Normal Saline (0.9% NaCl) is the first listed.
NCT01960348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01960348 about?
NCT01960348 is a clinical study titled "APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis". The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this stu...
What is the current status of trial NCT01960348?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2013-11. Estimated completion is 2017-08.
What interventions are being tested in trial NCT01960348?
The interventions under investigation include: Sterile Normal Saline (0.9% NaCl) (DRUG), patisiran (ALN-TTR02) (DRUG).
Who is sponsoring clinical trial NCT01960348?
This trial is sponsored by Alnylam Pharmaceuticals, which has 49 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01960348's enrollment target sits among peer trials
225 1311th of 2000 higher than 684 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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