- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108260
The Effectiveness of Recombinant Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: SHENG-CHIEH DR. CHOU, MD/PHD
- Phone Number: 70173 886223123456
- Email: potatoaureus@gmail.com
Study Contact Backup
- Name: YI-LIN YEH, Master
- Phone Number: 107 886227576970
- Email: yeh.yi-lin@cslbehring.com
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
-
Contact:
- SHENG-CHIEH CHOU, MD/PhD
- Phone Number: 70173 886223123456
- Email: potatoaureus@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single arm_Idelvion treated
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AsBR
Time Frame: 12 months
|
To evaluate AsBR of Idelvion in routine patient care
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201907004MIPB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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