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

NCT03417245 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-03-28

Study results available
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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

Interventions

DRUG

fitusiran

by SC injection

DRUG

factor concentrates

by intravenous (IV) injection

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2021-01-26
Completion
2021-07-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Denmark
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Malaysia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03417245 on ClinicalTrials.gov