CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
RIXUBISbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02937831
NCT02937831N/ACompleted

RIXUBIS Drug Use-Result Survey (Japan)

Baxalta now part of Shire·observational·Posted Oct 19, 2016·Updated Jul 22, 2024

In Brief

An observational study evaluating RIXUBIS for Hemophilia B. Completed, enrolled 6 participants across 5 sites.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesJapan
CollaboratorsTakeda

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 19, 2016
Enrollment StartNov 16, 2016
Primary CompletionMay 11, 2022
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 9.7 years ago

Interventions

RIXUBISbiological