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NCT03417245 · ClinicalTrials.gov registry record · Phase 3
A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors
A Phase 3 study of Hemophilia A and Hemophilia B, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT03417245 is a Phase 3 study of Hemophilia A and Hemophilia B that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 120 participants, above the 89-participant average among 42 other Hemophilia A trials with a reported enrollment target (35% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT03417245, a Phase 3 study of Hemophilia A and Hemophilia B, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: -To evaluate the efficacy of fitusiran compared to on-demand treatment with factor concentrates, as determined by the frequency of bleeding episodes. Secondary Objectives: * To evaluate the efficacy of fitusiran compared to on-demand treatment with factor concentrates, as determined by: * The frequency of spontaneous bleeding episodes. * The frequency of joint bleeding episodes. * Health-related quality of life (HRQOL) in participants \>=17 years of age. * To determine the frequency of bleeding episodes during the onset period. * To determine the safety and tolerability of fitusiran.
Conditions Studied
Interventions
- DRUG fitusiran
- DRUG factor concentrates
Study Locations (20)
Other
- Investigational Site Number 6101 - Camperdown
- Investigational Site Number 6103 - Murdoch
- Investigational Site Number 6104 - Prahran
- Investigational Site Number 8604 - Beijing
- Investigational Site Number 8602 - Guangzhou
- Investigational Site Number 8605 - Hangzhou
- Investigational Site Number 8603 - Shanghai
- Investigational Site Number 8601 - Tianjin
- Investigational Site Number 4501 - Copenhagen
- Investigational Site Number 3303 - Lyon
- Investigational Site Number 3305 - Paris
- Investigational Site Number 3301 - Rouen
Florida
- Investigational Site Number 128 - Gainesville
- Investigational Site Number 103 - Tampa
Arkansas
- Investigational Site Number 0140 - Little Rock
Illinois
- Investigational Site Number 102 - Chicago
Louisiana
- Investigational Site Number 119 - New Orleans
Michigan
- Investigational Site Number 125 - Ann Arbor
Nevada
- Investigational Site Number 111 - Las Vegas
Ohio
- Investigational Site Number 110 - Akron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2021-07-14 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03417245
The ClinicalTrials.gov registry entry for NCT03417245 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 89-participant average among 42 other Hemophilia A trials with a reported enrollment target (35% higher). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hemophilia A appearing as the primary indexed condition, and to 2 interventions - of which fitusiran is the first listed.
NCT03417245 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT03417245 about?
NCT03417245 is a clinical study titled "A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors". Primary Objective: -To evaluate the efficacy of fitusiran compared to on-demand treatment with factor concentrates, as determined by the frequency of bleeding episodes. Secondary Objectives: * To evaluate the efficacy of fitusiran compared to on-demand treatment with factor concentrates, as deter...
What is the current status of trial NCT03417245?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2018-03-01. Estimated completion is 2021-07-14.
What conditions does trial NCT03417245 study?
This clinical trial studies the following conditions: Hemophilia A, Hemophilia B.
What interventions are being tested in trial NCT03417245?
The interventions under investigation include: fitusiran (DRUG), factor concentrates (DRUG).
Who is sponsoring clinical trial NCT03417245?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03417245 being conducted?
This trial has 20 study locations across Arkansas, Florida, Illinois, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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