Recombinant Factor IX
Treatment for Hemophilia
Typical Dosage: Prophylaxis: 25-100 IU/kg 1-2 times per week; On-demand: 10-60 IU/kg
Effectiveness
90%
Safety Score
68%
Clinical Trials
61
Participants
30K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
68
DangerousModerateSafe
Treatment Details
Dosage Range
Prophylaxis: 25-100 IU/kg 1-2 times per week; On-demand: 10-60 IU/kg
Time to Effect
immediate
Treatment Duration
lifetime
Evidence Quality
HIGHNumber Needed to Treat (NNT)
2(Treat 2 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
50(Treat 50 patients to see 1 additional serious adverse event)
Confidence Score
95%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$300,000
Monitoring:$5,000
Side Effect Mgmt:$5,000
Total Annual:$310,000
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
GOODICER
$85,000/QALY
QALYs Gained
0.3
Outcome-Based Costs
Cost per Responder
$326,315.79
Comparison vs On-demand Factor IX
Cost Difference
+$120,000/year
More expensive
QALY Difference
+0.30 QALYs
Better outcomes
Dominance
No dominance
Recombinant Factor IX Outcomes
for Hemophilia
Efficacy Outcomes
Overall Effectiveness
+90%
Response Rate
+95%
Common Side Effects
Inhibitor development
+3%
Allergic reactions
+0.5%
Injection site reactions
+3%
Active Clinical Trials
No active trials currently recruiting for this treatment
No active trials found in ClinicalTrials.gov
Completed Clinical Trials
19 completed trials for Recombinant Factor IX in Hemophilia
Factor IX as Adjunctive Therapy to Emicizumab (EMIX)
NCT05281718COMPLETEDEARLY_PHASE1
12 participants
INTERVENTIONAL
Metairie, United States +1 more
Started: Aug 1, 2022
Study of Next-Generation Recombinant Factor IX Variant in Adult Subjects With Hemophilia B
NCT03995784COMPLETEDPHASE2
6 participants
INTERVENTIONAL
Johannesburg, South Africa
Started: Jun 18, 2019
BAX 326 Surgery Study in Hemophilia B Patients
NCT01507896COMPLETEDPHASE3
30 participants
INTERVENTIONAL
Rosario, Argentina +13 more
Started: Dec 19, 2011
Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients
NCT01174446COMPLETEDPHASE3
86 participants
INTERVENTIONAL
Rosario, Argentina +24 more
Started: Jul 29, 2010
Nonacog Alfa Prophylaxis And Treatment Of Bleeding Episodes In Previously Treated Patients With Hemophilia B
NCT04286412COMPLETEDPHASE4
25 participants
INTERVENTIONAL
Surat, India +4 more
Started: Feb 10, 2020
BeneFIX Drug Use Results Survey [All-Case Surveillance]
NCT01154231COMPLETED
314 participants
OBSERVATIONAL
Shinjuku-ku, Japan
Started: Oct 29, 2009
Efficacy and Safety of AlphaNine Versus BeneFIX in Patients With Severe Hereditary Haemophilia B
NCT03091751COMPLETEDPHASE2
13 participants
INTERVENTIONAL
Pleven, Bulgaria +2 more
Started: Aug 1, 2005
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
NCT02922231COMPLETED
57 participants
OBSERVATIONAL
Daegu, South Korea +4 more
Started: Jan 6, 2017
Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B
NCT00364182COMPLETEDPHASE3
50 participants
INTERVENTIONAL
Phoenix, United States +18 more
Started: May 1, 2007
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B
NCT01662531COMPLETEDPHASE3
27 participants
INTERVENTIONAL
Parkville, Australia +16 more
Started: Jan 1, 2013
Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
NCT00866606COMPLETEDPHASE3
35 participants
INTERVENTIONAL
Guangzhou, China +5 more
Started: Feb 1, 2009
Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B
NCT01027364COMPLETEDPHASE3
123 participants
INTERVENTIONAL
Phoenix, United States +50 more
Started: Dec 1, 2009
Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B
NCT00768287COMPLETEDPHASE2, PHASE3
77 participants
INTERVENTIONAL
Duarte, United States +22 more
Started: Jan 1, 2009
Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B
NCT01425723COMPLETEDPHASE3
120 participants
INTERVENTIONAL
Phoenix, United States +48 more
Started: Dec 8, 2011
Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS
NCT02190149COMPLETED
64 participants
OBSERVATIONAL
Los Angeles, United States +16 more
Started: Jul 22, 2014
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
NCT01496274COMPLETEDPHASE2, PHASE3
63 participants
INTERVENTIONAL
Chicago, United States +29 more
Started: Feb 1, 2012
Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B
NCT02234310COMPLETEDPHASE3
33 participants
INTERVENTIONAL
Sacramento, United States +26 more
Started: Nov 13, 2014
An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B
NCT02213250COMPLETEDPHASE1
12 participants
INTERVENTIONAL
Beijing, China +1 more
Started: Mar 1, 2015
Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B
NCT00581126COMPLETEDPHASE4
14 participants
INTERVENTIONAL
Started: Dec 1, 2001
Showing 20 of 61 total trials