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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-08

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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group A

Participants will be assigned to group A or B with a scale of 1:1 , i.e. infuse reference drug Xyntha (group A), then experimental drug (group B). All participants who completed the study will enter the prophylaxis group study.

Group Type EXPERIMENTAL

Xyntha

Intervention Type DRUG

Recombinant Coagulation Factor VIII Injection produced by Pfizer Inc.

Recombinant Coagulation Factor VIII Injection

Intervention Type DRUG

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

group B

Participants will be assigned to group A or B with a scale of 1:1 , i.e. infuse experimental drug (group B), then reference drug Xyntha (group A). All participants who completed the study will enter the prophylaxis group study.

Group Type EXPERIMENTAL

Xyntha

Intervention Type DRUG

Recombinant Coagulation Factor VIII Injection produced by Pfizer Inc.

Recombinant Coagulation Factor VIII Injection

Intervention Type DRUG

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

Interventions

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Xyntha

Recombinant Coagulation Factor VIII Injection produced by Pfizer Inc.

Intervention Type DRUG

Recombinant Coagulation Factor VIII Injection

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No