Status:
UNKNOWN
Pharmacokinetics Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Hemophilia A
Eligibility:
All Genders
12-65 years
Phase:
PHASE1
Brief 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 sequenc...
Eligibility Criteria
Inclusion
- Hemophilia A.
- 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
- Has a history or family history of blood coagulation factor VIII inhibitor.
- Has other coagulation dysfunction diseases in addition to hemophilia A.
- HIV positive.
- Plan to receive surgery during the trial.
- Has used immunomodulator within one weeks before the first dose，and less than 7 half-life periods.
- Known to be allergic to experimental drugs or any excipients.
- Severe anemia and need blood transfusion.
- Serious liver or kidney damage.
- Serious heart disease.
- Uncontrollable hypertension.
- Has participated in other clinical studies within one month before the first dose.
- The researchers believe that it is not suitable for participants.
Key Trial Info
Start Date :
May 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04060836
Start Date
May 8 2019
End Date
March 1 2020
Last Update
August 19 2019
Active Locations (5)
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1
AnHui Provincial Hospital
Hefei, Anhui, China, 230001
2
The First Hospital of LanZhou University
Lanzhou, Gansu, China, 730000
3
HeNan Cancer Provincial Hospital
Zhengzhou, Henan, China, 450008
4
Xiangya Hospital Central South University
Changsha, Hunan, China, 410013