Safety, Efficacy Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.
NCT ID: NCT04061109
Last Updated: 2019-08-19
Study Results
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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UNKNOWN
PHASE3
64 participants
INTERVENTIONAL
2019-05-15
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Prophylactic therapy
Subjects received Recombinant Human Coagulation FVIII for prophylactic therapy with 25 - 35 IU/kg injection once every other day or three times per week for 6 months.
Recombinant Human Coagulation FVIII
A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.
Interventions
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Recombinant Human Coagulation FVIII
A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
12 Years
65 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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AnHui Provincial Hospital
Hefei, Anhui, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
FuJian Medical University Union Hospital
Fuzhou, Fujian, China
The First Hospital of LanZhou University
Lanzhou, Gansu, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
HeNan Provincial Peoples Hospital
Zhengzhou, Henan, China
HeNan Cancer Provincial Hospital
Zhengzhou, Henan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTTQ-NXBYZ-02
Identifier Type: -
Identifier Source: org_study_id
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