Brief Title
Pharmacokinetics Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.
Official Title
Randomized, Open-label, Double Cycle, Crossover, Pharmacokinetics Study of Recombinant Coagulation Factor VIII Injection Versus Xyntha® in Subjects With Hemophilia A.
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 sequence (group B). All participants who completed the study will enter the
Prophylactic Therapy Study.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Pharmacokinetic parameters between test preparation and reference preparation, peak plasma concentration (Cmax)
Secondary Outcome
tmax
Condition
Hemophilia A
Intervention
Xyntha
Study Arms / Comparison Groups
group A
Description: Participants will be assigned to group A or B with a scale of 1:1 , i.e. infuse reference drug Xyntha (group A), then experimental drug (group B). All participants who completed the study will enter the prophylaxis group study.
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
24
Start Date
May 8, 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. 9）Has not received an treatment of any
FVIII within 4 days before the first dose.
10）Non-bleeding state.
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
NCT04060836
Organization ID
CTTQ-NXBYZ-02-PK
Responsible Party
Sponsor
Study Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Sponsor
, ,
Verification Date
August 2019