StudyFinder

EFC17574: A Phase 3, single-arm, multicenter, multinational, open label, one-way crossover study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged >= 12 years with severe hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX

Recruiting

A study to test a medicine (fitusiran) injected under the skin for preventing bleeding episodes in male adolescent or adult participants with severe Hemophilia.

I'm interested

Male
Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 12 years or older
• diagnosis of severe congenital hemophilia A or B
• participants currently not on prophylaxis (CFC or BPA on-demand): A minimum of 4 bleeding episodes requiring BPA (inhibitor participants) or CFC (non-inhibitor participants) treatment within the last 6 months
Exclusion Criteria:

• co-existing bleeding disorders other than congenital hemophilia A or B
• current participation in immune tolerance induction therapy (ITI)
• prior treatment with gene therapy
• acute hepatitis, ie, hepatitis A, hepatitis E, acute or chronic hepatitis B infection
• additional exclusion criteria apply (study staff will review)

Drug: Antithrombin concentrate (ATIIIC), Drug: Clotting factor concentrates (CFC) or bypassing agents (BPA), Drug: Fitusiran

Blood Disorders

Hemophilia

Diondra Howard - howar709@umn.edu
Jacob Cogan
PHASE3
STUDY00017896
See this study on ClinicalTrials.gov

Back