Data from Clinicaltrials.gov - Curated by EPG Health - Last updated 05 March 2018

This randomized, multicenter, open-label, Phase 3 study is designed to investigate the efficacy, safety, and pharmacokinetics of emicizumab in participants with hemophilia A regardless of factor VIII (FVIII) inhibitor status.

purpose

This randomized, multicenter, open-label, Phase 3 study is designed to investigate the efficacy, safety, and pharmacokinetics of emicizumab in participants with hemophilia A regardless of factor VIII (FVIII) inhibitor status. Participants who received episodic therapy with FVIII or bypassing agents prior to study entry and experienced at least 5 bleeds over the prior 24 weeks will be randomized in a 2:2:1 ratio to the following regimens: 1) Emicizumab prophylaxis at 3 milligrams per kilogram (mg/kg) every week (QW) subcutaneously (SC) for 4 weeks, followed by 1.5 mg/kg QW SC; 2) Emicizumab prophylaxis at 3 mg/kg QW SC for 4 weeks, followed by 6 mg/kg every 4 weeks (Q4W) SC; 3) No prophylaxis (control arm).


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Patients
Anticipated Study Start Date: April 28, 2018
Estimated Primary Completion Date: August 28, 2019
Estimated Study Completion Date: February 18, 2020

Arms and Interventions:
- Experimental:
Prophylactic Emicizumab 1.5 mg/kg QW
- Experimental: Prophylactic Emicizumab 6 mg/kg Q4W
- Control Arm: No Prophylaxis

Category Value
Date last updated at source 19-Feb-18
Study type(s) Interventional
Expected enrolment 70
Study start date 28-Apr-18
Estimated primary completion date 28-Aug-19

View full details

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Oral Anticoagulation Reversal

Oral Anticoagulation Reversal

Experts discuss the use of non-vitamin K oral anticoagulants in the treatment and prevention of stroke, deep vein thrombosis and pulmonary embolism in atrial fibrillation patients.

Chronic Lymphocytic Leukaemia (CLL)

Chronic Lymphocytic Leukaemia (CLL)

Refine your knowledge of chronic lymphocytic leukaemia (CLL) with information on pathophysiology, diagnosis, treatment options and more

+ 1 more

Chronic Spontaneous Urticaria (CSU)

Chronic Spontaneous Urticaria (CSU)

Use our patient case studies to discover how experts diagnose and treat chronic spontaneous urticaria.

+ 7 more

Load more

Related Content