Trials / Completed
CompletedNCT01960348
APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis
APOLLO: A Phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Patisiran (ALN-TTR02) in Transthyretin (TTR)-Mediated Polyneuropathy (Familial Amyloidotic Polyneuropathy-FAP)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 225 (actual)
- Sponsor
- Alnylam Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- TTR-mediated Amyloidosis
- Amyloidosis, Hereditary
- Amyloid Neuropathies, Familial
- Familial Amyloid Polyneuropathies
- Amyloid Neuropathies
- Amyloidosis, Hereditary, Transthyretin-Related
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | patisiran (ALN-TTR02) | administered by intravenous (IV) infusion |
| DRUG | Sterile Normal Saline (0.9% NaCl) | administered by intravenous (IV) infusion |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2017-08-01
- Completion
- 2017-08-01
- First posted
- 2013-10-10
- Last updated
- 2024-04-22
- Results posted
- 2018-09-06
Locations
52 sites across 21 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Cyprus, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Portugal, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT01960348. Inclusion in this directory is not an endorsement.