This is a multi-center, open-label, single-arm trial to evaluate the efficacy and safety of Recombinant Coagulation Factor VIII in patients with hemophilia A . Recombinant Coagulation Factor VIII is prophylactic administrated 25 - 35 IU/kg once every other day or three times per week which should be continuous for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
64
A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.
AnHui Provincial Hospital
Hefei, Anhui, China
RECRUITINGThe Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGAnnualized joint bleeding rate
Annualized joint bleeding rate(AJBR) can be calculated using the following formula: Number of joint bleeding events during efficacy evaluation period/(number of days in treatment period/365.25).
Time frame: up to 24 weeks
Incremental Recovery of the First Dose
Peak activity of FVIII (as Cmax) measured within 1 hour after the end of injection
Time frame: After the first dose on day 1
Bleeding Event Treatment Efficacy
The investigator shall evaluate the hemostatic effect after the treatment of every bleeding event of subjects based on a four-point scale(excellent, good, moderate, not relieved).
Time frame: up to 24 weeks
Monthly Average Number of Bleedings
Number of bleeding events in each month.
Time frame: up to 24 weeks
The number and dose of injection of Recombinant Human Coagulation FVIII required per bleeding episode
The number and dose of injection of Recombinant Human Coagulation FVIII required per bleeding episode
Time frame: up to 24 weeks
Incremental Recovery of Duplicated Dose
Peak activity of FVIII (as Cmax) measured within 1 hour after the end of injection.
Time frame: up to 12 weeks, 24 weeks
Hemophilia Joint Health Score (HJHS)
The scale assesses the functional status of the six major joints of the elbow, knee, and ankle, including: joint swelling, swelling duration, muscle atrophy, muscle strength, joint friction, joint pain, joint extension, joint flexion Degree decline, overall gait, etc.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
FuJian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGThe First Hospital of LanZhou University
Lanzhou, Gansu, China
RECRUITINGThe First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGHeNan Provincial Peoples Hospital
Zhengzhou, Henan, China
RECRUITINGHeNan Cancer Provincial Hospital
Zhengzhou, Henan, China
RECRUITINGXiangya Hospital Central South University
Changsha, Hunan, China
RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGJiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
RECRUITING...and 1 more locations
Time frame: Baseline, week 24
Assess the impact of Recombinant Human Coagulation FVIII following Patient Reported Outcome (PRO) EQ-5D
EQ-5D is a general questionnaire designed to measure health status on a scale of 0-100 with the higher value representing a better outcome and record the participants' current health state in 5 domains mobility, selfcare, usual activities, pain, anxiety.
Time frame: Baseline, week 24