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

August 16, 2019 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
        • Principal Investigator:
          • Yaming Xi
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • HeNan Cancer Provincial Hospital
        • Principal Investigator:
          • Hu Zhou
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Recruiting
        • Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Xyntha
Recombinant Coagulation Factor VIII Injection produced by Pfizer Inc.
Drug: Recombinant Coagulation Factor VIII Injection
A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.
Experimental: 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.
Drug: Xyntha
Recombinant Coagulation Factor VIII Injection produced by Pfizer Inc.
Drug: Recombinant Coagulation Factor VIII Injection
A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters between test preparation and reference preparation, peak plasma concentration (Cmax)
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.
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.
Pharmacokinetic parameters between Recombinant Coagulation Factor VIII, Area under the plasma concentration verus time curve(AUC)
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 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.
Incremental recovery between test preparation and reference preparation
Time Frame: up to 24 weeks
Peak activity of FVIII (as Cmax) measured within 1 hour after the end of infusion.
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tmax
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 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.
t1/2
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.
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.
Mean time of residence (MRT)
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.
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.
λz
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 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.
CL
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.
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.
Vz
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.
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)
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.
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.
Peak plasma concentration (Cmax)
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.
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.
Recombinant Coagulation Factor VIII multiple dose:tmax
Time Frame: On the 176th day after the prevention of medication
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
Recombinant Coagulation Factor VIII multiple dose:t1/2
Time Frame: On the 176th day after the prevention of medication
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of half-life.
On the 176th day after the prevention of medication
Recombinant Coagulation Factor VIII multiple dose:λz
Time Frame: On the 176th day after the prevention of medication
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of terminal rate constant.
On the 176th day after the prevention of medication
Recombinant Coagulation Factor VIII multiple dose:CL
Time Frame: On the 176th day after the prevention of medication
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
Recombinant Coagulation Factor VIII multiple dose:Vz
Time Frame: On the 176th day after the prevention of medication
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

August 16, 2019

First Posted (Actual)

August 19, 2019

Study Record Updates

Last Update Posted (Actual)

August 19, 2019

Last Update Submitted That Met QC Criteria

August 16, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTTQ-NXBYZ-02-PK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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