A Study of BAX 888 in Male Adults With Severe Hemophilia A

NCT03370172 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-09-11

Study results available
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Summary

The main aim of this study is to check if there are side effects from BAX 888 and to determine the dose of BAX 888 for treating severe hemophilia A in male adults.

Participants will receive one infusion with BAX 888 at the hemophilia treatment center. During the study, participants will visit their study clinic multiple times.

Conditions

Interventions

DRUG

BAX 888

Participants will receive a single peripheral IV infusion of BAX 888 in Cohort 1 and 2 Day 0.

Sponsors & Collaborators

  • Baxalta Innovations GmbH, now part of Shire

    collaborator INDUSTRY
  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY
  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2024-07-09
Completion
2024-07-09
FDA Drug
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • Hungary
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03370172 on ClinicalTrials.gov