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The Effectiveness of Recombinant Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients

NCT ID: NCT04108260

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-21

Study Completion Date

2022-04-30

Brief Summary

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The pivotal clinical data support prolonged dosing intervals of up to 14 days for routine prophylaxis in hemophilia B patients. The majority of adult and pediatric patients using Idelvion for routine prophylaxis had a median annualized spontaneous bleeding rate (AsBR) of 0.00. The majority (99%) of bleeding episodes were managed successfully with one or two infusions, and 94% of bleeds were controlled with only one infusion regardless of the cause or location.

The rationale for this study is to collect the effectiveness and safety data of severe hemophilia B patients treated with Idelvion following institutional standard of care. It is the aim of this study to extend the results of the clinical trial program to a broader hemophilia B population, and to compare with current alternative factor IX treatments in Taiwan.

Detailed Description

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Conditions

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Hemophilia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm_Idelvion treated

Group Type EXPERIMENTAL

Albutrepenonacog Alfa 1 UNT [IDELVION]

Intervention Type DRUG

Clinical data will be collected from patients who suffered from hemophilia B, and switch from other FIX products to Idelvion as prophylaxis, prevention of bleeding (e.g. surgery) or treatment of bleeding.

Interventions

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Albutrepenonacog Alfa 1 UNT [IDELVION]

Clinical data will be collected from patients who suffered from hemophilia B, and switch from other FIX products to Idelvion as prophylaxis, prevention of bleeding (e.g. surgery) or treatment of bleeding.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male patients with age ≥ 20 years old
* Endogenous FIX activity ≤1 IU/dL,
* At least 50 exposure days (EDs) with FIX products,
* No detectable inhibitor to FIX or inhibitor history,
* Had a minimum of 2 nontrauma-induced bleeding episodes (any type or location) treated in the 6 months preceding study entry,
* The patient or patient's parents or legal authorized representative, as applicable, are capable to understand the study objectives and procedure, and sign the written consent,
* Accept that the supply of Idelvion might be stopped once the study is completed,
* Able to complete a diary during 12 months or 50 EDs, whichever comes first.

Exclusion Criteria

* Currently participating in an interventional clinical trial,
* Known hypersensitivity to any FIX product or hamster protein,
* Known inhibitor to FIX or inhibitor history,
* With other comorbidities which are not suitable for this study, at investigator's discretion,
* Not able to compliant with the prophylactic treatment,
* Lacking previous treatment and bleeding records.
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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SHENG-CHIEH DR. CHOU, MD/PHD

Role: CONTACT

[email protected]
886223123456 ext. 70173

YI-LIN YEH, Master

Role: CONTACT

[email protected]
886227576970 ext. 107

Facility Contacts

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SHENG-CHIEH CHOU, MD/PhD

Role: primary

[email protected]
886223123456 ext. 70173

Other Identifiers

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201907004MIPB

Identifier Type: -

Identifier Source: org_study_id