Pharmacokinetics Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.24 enrolled

Overview

This is a multi-center, open-label, randomized study. Participants will be assigned to A or B groups with a scale of 1:1 , i.e. infuse study drug followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the study will enter the Prophylactic Therapy Study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hemophilia A

Interventions

XynthaDRUG

Recombinant Coagulation Factor VIII Injection produced by Pfizer Inc.

Recombinant Coagulation Factor VIII InjectionDRUG

A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Hemophilia A. 2. FVIII:C \<1%. 3）12 and 65 years old. 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. 9）Has not received an treatment of any FVIII within 4 days before the first dose. 10）Non-bleeding state. Exclusion Criteria: 1. Has a history or family history of blood coagulation factor VIII inhibitor. 2. Has other coagulation dysfunction diseases in addition to hemophilia A. 3. HIV positive. 4. Plan to receive surgery during the trial. 5. Has used immunomodulator within one weeks before the first dose，and less than 7 half-life periods. 6. Known to be allergic to experimental drugs or any excipients. 7. Severe anemia and need blood transfusion. 8. Serious liver or kidney damage. 9. Serious heart disease. 10. Uncontrollable hypertension. 11. Has participated in other clinical studies within one month before the first dose. 12. The researchers believe that it is not suitable for participants.

Locations (5)

AnHui Provincial Hospital

Hefei, Anhui, China

RECRUITING

The First Hospital of LanZhou University

Lanzhou, Gansu, China

RECRUITING

HeNan Cancer Provincial Hospital

Zhengzhou, Henan, China

Outcomes

Primary Outcomes

Pharmacokinetic parameters between test preparation and reference preparation, peak plasma concentration (Cmax)

Cmax is the maximum plasma concentration of Recombinant Coagulation Factor VIII or metabolite(s).

Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

Pharmacokinetic parameters between Recombinant Coagulation Factor VIII, Area under the plasma concentration verus time curve(AUC)

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of area under the plasma concentration time curve from zero to infinity.

Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

Incremental recovery between test preparation and reference preparation

Peak activity of FVIII (as Cmax) measured within 1 hour after the end of infusion.

Time frame: up to 24 weeks

Secondary Outcomes

tmax

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of time to reach maximum plasma concentration

Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

t1/2

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of half-life

Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on multiple dose in day 5 to day 8.

Mean time of residence (MRT)

Central Contacts

Lei Zhang, Doctor

CONTACT

022-20909240 zhanglei1@ihcams.ac.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Xiangya Hospital Central South University

Changsha, Hunan, China

RECRUITING

Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

RECRUITING

MRT is the average time that drug molecules stay in the body after a quick intravenous injection.

Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

λz

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of terminal rate constant.

Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of apparent plasma clearance following intravenous injection.

Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of apparent volume of distribution.

Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

Area under the plasma concentration verus time curve (AUC)

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of area under the plasma concentration time curve from zero to infinity.

Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on multiple dose in day 5 to day 8.

Peak plasma concentration (Cmax)

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of maximum plasma concentration.

Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on multiple dose in day 5 to day 8.

Recombinant Coagulation Factor VIII multiple dose:tmax

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of time to reach maximum plasma concentration.

Time frame: On the 176th day after the prevention of medication

Recombinant Coagulation Factor VIII multiple dose:t1/2

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of half-life.

Time frame: On the 176th day after the prevention of medication

Recombinant Coagulation Factor VIII multiple dose:λz

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of terminal rate constant.

Time frame: On the 176th day after the prevention of medication

Recombinant Coagulation Factor VIII multiple dose:CL

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of apparent plasma clearance following intravenous injection.

Time frame: On the 176th day after the prevention of medication

Recombinant Coagulation Factor VIII multiple dose:Vz

To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of apparent volume of distribution.

Time frame: On the 176th day after the prevention of medication