Status:
UNKNOWN
The Effectiveness of Recombinant Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Hemophilia
Eligibility:
MALE
20+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04108260
Start Date
April 21 2020
End Date
April 1 2022
Last Update
October 30 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, Taiwan