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Clinical trial

A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors (HAVEN 2)

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Last updated:21st Jul 2016
Identifier: NCT02795767

This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This study will open two additional non-randomized cohorts to investigate Q2W and Q4W regimens in pediatric participants.

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 88 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Administration of Emicizumab in Hemophilia A Pediatric Patients With Inhibitors
Actual Study Start Date: July 22, 2016
Estimated Primary Completion Date: April 30, 2018
Estimated Study Completion Date: February 1, 2019

Arms and Interventions:
- Experimental:
Cohort A: Emicizumab QW
- Experimental: Cohort B: Emicizumab Q2W
- Experimental: Cohort C: Emicizumab Q4W

Category Value
Date last updated at source 2018-01-18
Study type(s) Interventional
Expected enrolment 88
Study start date 2016-07-22
Estimated primary completion date 2018-04-30

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