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COMPLETED Phase 3

A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors

NCT03417245 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 120 participants
Start Date 2018-03-01
Est. Completion 2021-07-14
Phase Phase 3

Sponsor

Genzyme, a Sanofi Company

52 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 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 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03417245 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Florida, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03417245?

The interventions under investigation include: fitusiran (DRUG), factor concentrates (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03417245?

This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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