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NCT03997383 · ClinicalTrials.gov registry record · Phase 3
APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
A Phase 3 study of Transthyretin Amyloidosis (ATTR) With Cardiomyopathy, sponsored by Alnylam Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 360
- Enrollment target
- 20
- Study locations
NCT03997383: Active Phase 3 study of Transthyretin Amyloidosis (ATTR) With Cardiomyopathy, sponsored by Alnylam Pharmaceuticals.
NCT03997383 is a Phase 3 study of Transthyretin Amyloidosis (ATTR) With Cardiomyopathy that is active but no longer recruiting, run by Alnylam Pharmaceuticals. The registered enrollment target is 360 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03997383, a Phase 3 study of Transthyretin Amyloidosis (ATTR) With Cardiomyopathy, is active but no longer recruiting, sponsored by Alnylam Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 360 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of patisiran in participants with ATTR amyloidosis with cardiomyopathy.
Primary Outcome
Distance in meters walked in 6 minutes, longer distances indicate greater functional capacity. Missing 6MWT values due to non-COVID-19 death or inability to walk due to ATTR disease progression were imputed using the worst 10th percentile change observed in the DB period. Missing 6-MWT values due to other reasons are multiply imputed to create 100 complete datasets. The change from baseline is averaged across the 100 complete datasets.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Patisiran
Study Locations (20)
Pennsylvania
- Clinical Trial Site - Philadelphia
- Clinical Trial Site - Philadelphia
- Clinical Trial Site - Pittsburgh
Illinois
- Clinical Trial Site - Chicago
- Clinical Trial Site - Skokie
Massachusetts
- Clinical Trial Site - Boston
- Clinical Trial Site - Burlington
New York
- Clinical Trial Site - New York
- Clinical Trial Site - New York
California
- Clinical Trial Site - Los Angeles
Iowa
- Clinical Trial Site - Iowa City
Kansas
- Clinical Trial Site - Kansas City
Maryland
- Clinical Trial Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2019-09-12 |
| Est. Completion | 2027-03-15 |
| Phase | Phase 3 |
What the registry record for NCT03997383 still lists
NCT03997383 is an interventional study that assigns participants to a tested intervention. The registered 360 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 (53% lower).
The record links to 1 condition, with Transthyretin Amyloidosis (ATTR) With Cardiomyopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03997383 names 20 study sites across 15 states, led by Pennsylvania, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03997383 about?
NCT03997383 is a clinical study titled "APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)". The purpose of this study is to evaluate the efficacy and safety of patisiran in participants with ATTR amyloidosis with cardiomyopathy.
What is the current status of trial NCT03997383?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2019-09-12. Estimated completion is 2027-03-15.
What conditions does trial NCT03997383 study?
This clinical trial studies the following conditions: Transthyretin Amyloidosis (ATTR) With Cardiomyopathy.
What interventions are being tested in trial NCT03997383?
The interventions under investigation include: Placebo (DRUG), Patisiran (DRUG).
Who is sponsoring clinical trial NCT03997383?
This trial is sponsored by Alnylam Pharmaceuticals, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03997383 being conducted?
This trial has 20 study locations across California, Illinois, Iowa, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03997383's enrollment target sits among peer trials
360 1008th of 2000 higher than 980 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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