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:
Active Clinical Trials
2 active trials recruiting for Recombinant Factor VIII in Hemophilia
A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A
NCT06297655NOT YET RECRUITINGPHASE3
60 participants
INTERVENTIONAL
Hefei, China +10 more
Started: Apr 1, 2024
POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies
NCT04690322RECRUITINGPHASE4
28 participants
INTERVENTIONAL
Dallas, United States
Started: Apr 15, 2021
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 352 total trials