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FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)

NCT02764489 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-02-14

Study results available
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Summary

The purpose of this study is to:

* 1\. To evaluate the tolerability and safety of infusing reduced volume Factor Eight Inhibitor Bypassing Activity (FEIBA) at the standard infusion rate of 2 U/kg/min
* 2\. To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased rates of 4 and 10 U/kg/min, in comparison to the standard rate of 2 U/kg/min at the regular volume

Conditions

  • Hemophilia A or B With Inhibitors

Interventions

BIOLOGICAL

FEIBA

Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate \[APCC\]), FEIBA NF.

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
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2021-12-27
Completion
2021-12-27
FDA Drug
Yes

Countries

  • Croatia
  • North Macedonia
  • Ukraine

Study Locations

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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 NCT02764489 on ClinicalTrials.gov