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BAX 802 in CHA With Inhibitors

NCT02895945 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-10-20

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective surgical, dental, or other invasive procedures.

Conditions

Interventions

BIOLOGICAL

Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802)

In case of major surgery, FVIII target level is ≥80% for major surgeries/ procedures and ≥50% for minor surgeries/ procedures.

Sponsors & Collaborators

  • Baxalta Innovations GmbH, now part of Shire

    collaborator INDUSTRY

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-12-22
Primary Completion
2021-01-22
Completion
2021-01-22
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Russia
  • South Africa
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

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 NCT02895945 on ClinicalTrials.gov