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

Hemophilia A Clinical Trial

Official title:

Randomized, Open-label, Double Cycle, Crossover, Pharmacokinetics Study of Recombinant Coagulation Factor VIII Injection Versus Xyntha® in Subjects With Hemophilia A.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04060836
• Other study ID #: CTTQ-NXBYZ-02-PK
• Status: Recruiting
• Phase: Phase 1
• Start date: May 8, 2019
• Est. completion date: March 2020

Study information

• Verified date: August 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Lei Zhang, Doctor
• Phone: 022-20909240
• Email: zhanglei1[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Drug:
• Xyntha
Recombinant Coagulation Factor VIII Injection produced by Pfizer Inc.
• Recombinant Coagulation Factor VIII Injection
A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha	Hunan
China	AnHui Provincial Hospital	Hefei	Anhui
China	The First Hospital of LanZhou University	Lanzhou	Gansu
China	Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences	Tianjin	Tianjin
China	HeNan Cancer Provincial Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.
Primary	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.	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.
Primary	Incremental recovery between test preparation and reference preparation	Peak activity of FVIII (as Cmax) measured within 1 hour after the end of infusion.	up to 24 weeks
Secondary	tmax	To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of time to reach maximum plasma concentration	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.
Secondary	t1/2	To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of half-life	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.
Secondary	Mean time of residence (MRT)	MRT is the average time that drug molecules stay in the body after a quick intravenous injection.	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.
Secondary	?z	To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of terminal rate constant.	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.
Secondary	CL	To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of apparent plasma clearance following intravenous injection.	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.
Secondary	Vz	To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of apparent volume of distribution.	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.
Secondary	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.	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.
Secondary	Peak plasma concentration (Cmax)	To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of maximum plasma concentration.	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.
Secondary	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.	On the 176th day after the prevention of medication
Secondary	Recombinant Coagulation Factor VIII multiple dose:t1/2	To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of half-life.	On the 176th day after the prevention of medication
Secondary	Recombinant Coagulation Factor VIII multiple dose:?z	To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of terminal rate constant.	On the 176th day after the prevention of medication
Secondary	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.	On the 176th day after the prevention of medication
Secondary	Recombinant Coagulation Factor VIII multiple dose:Vz	To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of apparent volume of distribution.	On the 176th day after the prevention of medication