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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 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 60 participants.

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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).

Interventions

  • DRUG fitusiran
  • DRUG Bypassing agents

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2018-02-14
Est. Completion 2021-06-23
Phase Phase 3

Sponsor

Genzyme, a Sanofi Company

196 total trials

What the Registry Record Tells You About NCT03417102

The ClinicalTrials.gov registry entry for NCT03417102 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 60 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 2 interventions - of which fitusiran is the first listed.

NCT03417102 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.