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

Last updated: August 16, 2019
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Hemophilia

Treatment

N/A

Clinical Study ID

NCT04060836
CTTQ-NXBYZ-02-PK
  • Ages 12-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 bleedingtreatment records of at least 3 months before randomization. 6)FVIII inhibitor assayresults 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 anyFVIII within 4 days before the first dose.

10)Non-bleeding state.

Exclusion

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 7half-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 Design

Total Participants: 24
Study Start date:
May 08, 2019
Estimated Completion Date:
March 31, 2020

Connect with a study center

  • AnHui Provincial Hospital

    Hefei, Anhui 230001
    China

    Active - Recruiting

  • The First Hospital of LanZhou University

    Lanzhou, Gansu 730000
    China

    Active - Recruiting

  • HeNan Cancer Provincial Hospital

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

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