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

Primary Purpose

Hemophilia

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Albutrepenonacog Alfa 1 UNT [IDELVION]
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm_Idelvion treated

Arm Description

Outcomes

Primary Outcome Measures

AsBR
To evaluate AsBR of Idelvion in routine patient care

Secondary Outcome Measures

Full Information

First Posted
September 26, 2019
Last Updated
October 28, 2020
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04108260
Brief Title
The Effectiveness of Recombinant Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients
Official Title
The Effectiveness of Recombinant Fusion Protein Linking Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients Switching From Previous Factor IX Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 21, 2020 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm_Idelvion treated
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Albutrepenonacog Alfa 1 UNT [IDELVION]
Intervention Description
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.
Primary Outcome Measure Information:
Title
AsBR
Description
To evaluate AsBR of Idelvion in routine patient care
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SHENG-CHIEH DR. CHOU, MD/PHD
Phone
886223123456
Ext
70173
Email
potatoaureus@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
YI-LIN YEH, Master
Phone
886227576970
Ext
107
Email
yeh.yi-lin@cslbehring.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SHENG-CHIEH CHOU, MD/PhD
Phone
886223123456
Ext
70173
Email
potatoaureus@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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