A Phase 3 interventional study of Recombinant Human Coagulation FVIII in Hemophilia A, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Status unknown at 11 sites in China. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-19.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 3, Interventional, and Prevention
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.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's planned enrollment of 64 is above the median of 28 across 512 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
4）Has received FVIII treatment and the treatment exposure days ≥100. 5）Has bleeding treatment records of at least 3 months before randomization. 6）FVIII inhibitor assay results is negative. 7） Subjects should agree to use an adequate method of contraception during the study.
8）Understood and Signed an informed consent form.
Exclusion Criteria:
Subjects received Recombinant Human Coagulation FVIII for prophylactic therapy with 25 - 35 IU/kg injection once every other day or three times per week for 6 months.
Drug: Recombinant Human Coagulation FVIII
A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.
Annualized 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.
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
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.