Clinical Trial – Fitusiran (ALN-AT3SC) – Hemophilia A and Hemophilia B

Alnylam Pharmaceuticals is running a clinical trial to test drugs called fitusiran and recombinant Factor VIIa and FEIBA. The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).

The drugs are fitusiran and recombinant Factor VIIa and FEIBA.

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Contacts

Contact: Alnylam Clinical Trials 866-330-0326 clinicaltrials@alnylam.com

NCT Number

NCT number: NCT03417102

For enrollment please visit www.clinicaltrials.gov.

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