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RIXUBIS Drug Use-Result Survey (Japan)

NCT02937831 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2024-07-22

Study results available
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Summary

The purpose of this survey is to understand the following items observed in the actual clinical use of RIXUBIS.

1. Unexpected adverse drug reactions
2. Occurrence of adverse drug reactions in the actual clinical use
3. Factors that may affect safety and effectiveness
4. Occurrence of Factor IX (FIX) inhibitor development in patients with coagulation FIX deficiency
5. Safety and effectiveness for hemophilia B patients who received routine prophylactic therapy, on-demand therapy and perioperative therapy

Conditions

  • Hemophilia B

Interventions

BIOLOGICAL

RIXUBIS

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-16
Primary Completion
2022-05-11
Completion
2022-05-11

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

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 NCT02937831 on ClinicalTrials.gov