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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 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 80 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03549871
The ClinicalTrials.gov registry entry for NCT03549871 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Fitusiran is the first listed.
NCT03549871 reports 0 study locations.
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.
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