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
For enrollment please visit www.clinicaltrials.gov.
