Study of Recombinant Human Coagulation Factor VIIa for Injection (FⅦa) in Patients With Hemophilia.

NCT ID: NCT04768699

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-12-01

Brief Summary

Aim of this trial is to assess the pharmacokinetics and pharmacodynamics (PK/PD) of recombinant human coagulation factor VIIa for injection (FⅦa) in patients with hemophilia.

Conditions

Hemophilia A With Inhibitor; Hemophilia B With Inhibitor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQG203(30µg/kg)

Group Type: EXPERIMENTAL

TQG203

Intervention Type: DRUG

TQG203,30µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.

TQG203(90µg/kg)

Group Type: EXPERIMENTAL

TQG203/NovoSeven®

Intervention Type: DRUG

In each of the two study periods (separated by a washout about two days),a single dose of TQG203 or NovoSeven® will be administered.TQG203 or NovoSeven®,90µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1.

NovoSeven®(90µg/kg)

NovoSeven®,manufactured by Novo Nordisk Inc.

Group Type: ACTIVE_COMPARATOR

TQG203/NovoSeven®

Intervention Type: DRUG

In each of the two study periods (separated by a washout about two days),a single dose of TQG203 or NovoSeven® will be administered.TQG203 or NovoSeven®,90µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1.

TQG203(180µg/kg)

Group Type: EXPERIMENTAL

TQG203

Intervention Type: DRUG

TQG203,180µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.

Interventions

TQG203

TQG203,30µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.

Intervention Type: DRUG

TQG203/NovoSeven®

In each of the two study periods (separated by a washout about two days),a single dose of TQG203 or NovoSeven® will be administered.TQG203 or NovoSeven®,90µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1.

Intervention Type: DRUG

TQG203

TQG203,180µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosed as congenital hemophilia A or B, and meet the following conditions: a. FⅧ<1% or FIX activity<2%; b. FⅧ inhibitor or FⅨ inhibitor titer in the screening period>5 BU (Nijmegen modified Bethesda method of detection).
• Age ≥18 and ≤75 years, male or female.
• No other drugs for the treatment of hemophilia have been used within 48 hours (2 days) before administration, including prothrombin complex and any FVII products, cryoprecipitate, fresh plasma and whole blood, etc.
• No obvious bleeding symptoms during PK medication (no active bleeding).
• Subjects of childbearing age agree to take effective contraceptive measures throughout the trial period, and continue to 28 days after the last medication.
• Volunteer to participate in this study, sign an informed consent form, have good compliance, and be able to cooperate with the experimental observation.

Exclusion Criteria

• Any other bleeding disease except Congenital hemophilia A or B.
• Patients with any previous medical history or symptoms of arterial or venous thromboembolic events (such as atherosclerosis, myocardial infarction, ischemic stroke, transient ischemic attack, deep vein thrombosis or pulmonary hypertension embolism) or disseminated intravascular coagulation (DIC).
• Baseline and previous values of FⅦ inhibitor or rFVIIa inhibitor is positive.
• Vitamin K deficiency.
• Human immunodeficiency virus (HIV) positive and cluster of differentiation 4 (CD4) count ≤200/μl, the number of virus carriers ≥200 particles/μl or ≥400000 copies/ml.
• Subjects plan to perform elective surgery during the trial period.
• Those who are allergic to test drugs or any excipients.
• Severe anemia and need blood transfusion.
• Platelet count <80×10^9/L.
• Obvious liver or kidney damage: ALT or AST>2.5×ULN, or total bilirubin>1.5×ULN or serum creatinine>1.5×ULN.
• Have a history of cardiac surgery and need anticoagulation therapy; severe heart disease, including myocardial infarction, cardiac insufficiency grade 3 or above, the current New York Heart Association cardiac function grade II-IV.
• Hypertension that cannot be controlled with drug treatment: systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg.
• Participated in other clinical studies (except FVIIa, FⅧ and FⅨ trials) within one month before the first medication.
• Diagnosed with hereditary diseases such as fructose intolerance, glucose malabsorption or sucrose-maltase deficiency.
• Alcoholism, drug abuse, mental disorders, other severe acute or chronic diseases, greater abnormal laboratory values, and those who are considered unsuitable by the researcher.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hematology Hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei Zhang, Doctor

Role: CONTACT

zhanglei1@ihcams.ac.cn

13502118379

Facility Contacts

Zhang Lei, Doctor

Role: primary

zhanglei1@ihcams.ac.cn

+86-13502118379

Other Identifiers

TQG203-I-01

Identifier Type: -

Identifier Source: org_study_id