Status:
UNKNOWN
Safety, Efficacy 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:
PHASE3
Brief Summary
This is a multi-center, open-label, single-arm trial to evaluate the efficacy and safety of Recombinant Coagulation Factor VIII in patients with hemophilia A . Recombinant Coagulation Factor VIII is p...
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.
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 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04061109
Start Date
May 15 2019
End Date
March 1 2020
Last Update
August 19 2019
Active Locations (11)
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1
AnHui Provincial Hospital
Hefei, Anhui, China, 230001
2
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
3
FuJian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
4
The First Hospital of LanZhou University
Lanzhou, Gansu, China, 730000