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NCT03417102 · ClinicalTrials.gov registry record · Phase 3
A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
NCT03417102: Completed Phase 3 study, sponsored by Genzyme, a Sanofi Company.
NCT03417102 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03417102, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this study was to determine the frequency of bleeding episodes in participants receiving fitusiran as prophylactic treatment of hemophilia compared to participants who were assigned to continue with their regular medication. In addition, the study assessed safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).
Primary Outcome
ABR for a participant during efficacy period (EP) was defined as annualized number of bleeding episodes during EP annualized to a 1-year interval of time. Treated Bleeding episode: any occurrence of hemorrhage that required administration of BPA or factor. It started from first sign of a bleed and ended no more than 72 hours after last treatment for bleed, within which any symptoms of bleeding at same location or injections less than or equal to 72 hours apart were considered the same bleeding e
Interventions
- DRUG fitusiran
- DRUG Bypassing agents
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-02-14 |
| Est. Completion | 2021-06-23 |
| Phase | Phase 3 |
What the finished NCT03417102 record still lists
NCT03417102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which fitusiran is the first listed.
NCT03417102 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03417102 about?
NCT03417102 is a clinical study titled "A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors". The purpose of this study was to determine the frequency of bleeding episodes in participants receiving fitusiran as prophylactic treatment of hemophilia compared to participants who were assigned to continue with their regular medication. In addition, the study assessed safety, quality of life, pha...
What is the current status of trial NCT03417102?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2018-02-14. Estimated completion is 2021-06-23.
What interventions are being tested in trial NCT03417102?
The interventions under investigation include: fitusiran (DRUG), Bypassing agents (DRUG).
Who is sponsoring clinical trial NCT03417102?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03417102's enrollment target sits among peer trials
60 1804th of 2000 higher than 177 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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