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
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
AsBR
Condition
Hemophilia
Intervention
Albutrepenonacog Alfa 1 UNT [IDELVION]
Study Arms / Comparison Groups
Single arm_Idelvion treated
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
5
Start Date
April 21, 2020
Completion Date
April 2022
Primary Completion Date
November 2021
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.
Gender
Male
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 886223123456, [email protected]
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT04108260
Organization ID
201907004MIPB
Responsible Party
Sponsor
Study Sponsor
National Taiwan University Hospital
Study Sponsor
, ,
Verification Date
October 2020