RIXUBIS Drug Use-Result Survey (Japan)

NCT ID: NCT02937831

Last Updated: 2024-07-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-16

Study Completion Date

2022-05-11

Brief Summary

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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

Detailed Description

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Conditions

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Hemophilia B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All Study Participants

RIXUBIS

Intervention Type BIOLOGICAL

Interventions

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RIXUBIS

Intervention Type BIOLOGICAL

Other Intervention Names

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Coagulation Factor IX [Recombinant] BAX 326 Recombinant factor IX BAX326

Eligibility Criteria

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Inclusion Criteria

* Patients with hemophilia B scheduled to receive treatment with RIXUBIS

Exclusion Criteria

* Patients not administered RIXUBIS
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role collaborator

Baxalta now part of Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Shire

Locations

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Seki-shi, Japan

Seki-shi, Gifu, Japan

Site Status

Maebashi-shi, Japan

Maebashi, Gunma, Japan

Site Status

Nobeoka-shi, Japan

Nobeoka-shi, Miyazaki, Japan

Site Status

Niigata-shi, Japan

Niigata, Niigata, Japan

Site Status

Osaka-shi, Japan

Osaka, Osaka, Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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251601

Identifier Type: -

Identifier Source: org_study_id

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