Brief Title
Safety, Efficacy Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.
Official Title
Multicenter, Noncontrol Study of Recombinant Coagulation Factor VIII for Prophylactic Therapy in Subjects With Hemophilia A.
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 prophylactic administrated 25 - 35 IU/kg once every other day or three times
per week which should be continuous for 24 weeks.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Annualized joint bleeding rate
Secondary Outcome
Bleeding Event Treatment Efficacy
Condition
Hemophilia A
Intervention
Recombinant Human Coagulation FVIII
Study Arms / Comparison Groups
Prophylactic therapy
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
64
Start Date
May 15, 2019
Completion Date
March 2020
Primary Completion Date
March 2020
Eligibility Criteria
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.
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.
Gender
All
Ages
12 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
, 022-20909240, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04061109
Organization ID
CTTQ-NXBYZ-02
Responsible Party
Sponsor
Study Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Sponsor
, ,
Verification Date
August 2019