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NCT03549871 · ClinicalTrials.gov registry record · Phase 3
A Study of Fitusiran in Severe Hemophilia A and B Patients Previously Receiving Factor or Bypassing Agent Prophylaxis
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
NCT03549871: Completed Phase 3 study, sponsored by Genzyme, a Sanofi Company.
NCT03549871 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03549871, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
Study Summary
Primary Objective: To characterize the frequency of bleeding episodes (BE) while receiving fitusiran treatment, relative to the frequency of bleeding episodes while receiving factor concentrate or bypassing agent (BPA) prophylaxis. Secondary Objectives: * To characterize the following while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis: * the frequency of spontaneous bleeding episodes * the frequency of joint bleeding episodes * health related quality of life (HRQOL) in participants greater than or equal to (\>=) 17 years of age * To characterize the frequency of bleeding episodes during the onset and treatment periods in participants receiving fitusiran. * To characterize the safety and tolerability of fitusiran. * To characterize the annualized weight-adjusted consumption of factor/BPA while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis.
Primary Outcome
Bleeding episodes (BE): any occurrence of hemorrhage might require administration of factor/BPA. BE start time: time at which 1st BE symptoms develop; bleeding/any symptoms at same location occurred within 72 hours of last injection used to treat BE at that location was considered part of original BE and counted as 1 BE towards ABR. Bleeding began after 72 hours of last injection at that location was considered as a new event. ABR = total number of qualifying BE/total number of days in the respe
Interventions
- DRUG Fitusiran
- DRUG BPA prophylaxis
- DRUG Factor (FVIII or FIX) prophylaxis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-07-25 |
| Est. Completion | 2022-03-25 |
| Phase | Phase 3 |
What the finished NCT03549871 record still lists
NCT03549871 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Fitusiran is the first listed.
NCT03549871 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03549871 about?
NCT03549871 is a clinical study titled "A Study of Fitusiran in Severe Hemophilia A and B Patients Previously Receiving Factor or Bypassing Agent Prophylaxis". Primary Objective: To characterize the frequency of bleeding episodes (BE) while receiving fitusiran treatment, relative to the frequency of bleeding episodes while receiving factor concentrate or bypassing agent (BPA) prophylaxis. Secondary Objectives: * To characterize the following while recei...
What is the current status of trial NCT03549871?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2018-07-25. Estimated completion is 2022-03-25.
What interventions are being tested in trial NCT03549871?
The interventions under investigation include: Fitusiran (DRUG), BPA prophylaxis (DRUG), Factor (FVIII or FIX) prophylaxis (DRUG).
Who is sponsoring clinical trial NCT03549871?
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 NCT03549871's enrollment target sits among peer trials
80 1755th of 2000 higher than 233 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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