Recombinant Factor VIII
Treatment for Hemophilia
Typical Dosage: Prophylaxis: 20-50 IU/kg 2-3 times per week; On-demand: 10-50 IU/kg
Effectiveness
90%
Safety Score
65%
Clinical Trials
351
Participants
50K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
65
DangerousModerateSafe
Treatment Details
Dosage Range
Prophylaxis: 20-50 IU/kg 2-3 times per week; On-demand: 10-50 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)
4(Treat 4 patients to see 1 additional serious adverse event)
Confidence Score
95%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$350,000
Monitoring:$5,000
Side Effect Mgmt:$10,000
Total Annual:$365,000
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
GOODICER
$80,000/QALY
QALYs Gained
0.3
Outcome-Based Costs
Cost per Responder
$384,210.53
Comparison vs On-demand Factor VIII
Cost Difference
+$150,000/year
More expensive
QALY Difference
+0.30 QALYs
Better outcomes
Dominance
No dominance
Recombinant Factor VIII Outcomes
for Hemophilia
Efficacy Outcomes
Overall Effectiveness
+90%
Response Rate
+95%
Common Side Effects
Inhibitor development
+25%
Allergic reactions
+0.5%
Injection site reactions
+3%
Sources:
WARNING: LIMITED TRIALS AVAILABLE
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Active Clinical Trials
No active trials currently recruiting for this treatment
No active trials found in ClinicalTrials.gov
Completed Clinical Trials
13 completed trials for Recombinant Factor VIII in Hemophilia
BAX 855 PK-guided Dosing
NCT02585960COMPLETEDPHASE3
135 participants
INTERVENTIONAL
Phoenix, United States +82 more
Started: Nov 23, 2015
An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A
NCT01486927COMPLETEDPHASE2, PHASE3
175 participants
INTERVENTIONAL
Sacramento, United States +55 more
Started: Feb 1, 2012
Canadian Hemophilia Prophylaxis Study
NCT01085344COMPLETEDPHASE4
56 participants
INTERVENTIONAL
Toronto, Canada
Started: Jun 26, 1997
ADYNOVATE Drug Use-Results Survey
NCT03169972COMPLETED
135 participants
OBSERVATIONAL
Nagoya, Japan +51 more
Started: Feb 1, 2017
Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
NCT00868530COMPLETEDPHASE3
53 participants
INTERVENTIONAL
Suzhou, China +5 more
Started: Sep 1, 2008
Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
NCT01810666COMPLETEDPHASE4
30 participants
INTERVENTIONAL
Guangzhou, China +4 more
Started: Mar 1, 2013
Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment
NCT00623480COMPLETEDPHASE3
84 participants
INTERVENTIONAL
Tucson, United States +37 more
Started: Mar 1, 2008
Drug Use Investigation of Kovaltry in Hemophilia A Patients
NCT02941783COMPLETED
230 participants
OBSERVATIONAL
Multiple Locations, Japan
Started: Nov 30, 2016
Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients
NCT00914459COMPLETEDPHASE4
37 participants
INTERVENTIONAL
Kuopio, Finland +16 more
Started: Dec 1, 2009
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543
NCT01238367COMPLETEDPHASE1
6 participants
INTERVENTIONAL
Itabashi-ku, Tokyo, Japan +5 more
Started: Nov 1, 2010
Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment
NCT02396862COMPLETED
272 participants
OBSERVATIONAL
Phoenix, United States +9 more
Started: Dec 9, 2015
An Open Label Study to Determine the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A.
NCT04456387COMPLETEDPHASE3
119 participants
INTERVENTIONAL
Hefei, China +16 more
Started: Oct 15, 2020
Phase III Expansion Trial for Determining the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A
NCT04845399COMPLETEDPHASE3
101 participants
INTERVENTIONAL
Hefei, China +15 more
Started: Apr 16, 2021
Showing 20 of 358 total trials