Clinical Study of Recombinant Human Activated Coagulation Factor VII for Injection in Patients With Hemophilia With Inhibitor

NCT05487976 | Unknown Phase 3

• 1 other identifier: TQG203-III-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

Brief Summary

Human coagulation factor VII is a vitamin K-dependent serine endogenous protease, and its activated form plays an important role in the coagulation process. Recombinant human activated coagulation factor VII is an activated state coagulation factor VII obtained by recombinant means.

Conditions

Hemophilia A; Hemophilia B

Outcome Measures

Primary Outcomes (2)

• Number of bleeding Effective rate of hemostasis

  Hemostasis is effective after the bleeding event if the bleeding event has not received other treatment within 12 hours since the first treatment and achieved moderate or above remission (based on the four-point scoring standard)

  Each new blood event was assessed within 12 hours of initial treatment

• Activity recovery of first dose

  The peak coagulation factor VII activity measured within 1 hour after the end of the infusion was subtracted from the baseline coagulation factor VII activity and expressed as \[IU/ml\]/\[IU/kg\].

  Within 1 hour of completion of infusion

Secondary Outcomes (10)

• Number of bleeding effective rate of hemostasis within 8 hours

  Each new blood event was assessed within 8 hours of initial treatment

• Number of bleeding effective rate continuous hemostatic

  Each new blood event was assessed within 24 hours of initial treatment

• Activity recovery after repeated administration

  Within 1 hour of completion of infusion

• Dose of injections for each new blood transfusion

  Up to 24 weeks.

• Number of injections for each new blood transfusion

  Up to 24 weeks.

Study Arms (1)

Recombinant human activated coagulation factor VII for injection

EXPERIMENTAL

Each subject in this study received on-demand treatment with recombinant human activated coagulation factor VII for injection for 24 weeks. The single dose for each bleeding event was 90 μg/kg, and the number of doses was increased according to the remission after treatment.

Drug: Recombinant human activated coagulation factor VII for injection

Interventions

Recombinant human activated coagulation factor VII for injection DRUG

Human coagulation factor VII is a vitamin K-dependent serine endogenous protease, and its activated form plays an important role in the coagulation process. Recombinant human activated coagulation factor VII is an activated state coagulation factor VII obtained by recombinant means.

Recombinant human activated coagulation factor VII for injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as congenital hemophilia A or B, and meet the following conditions:
• FⅧ\<1% or FIX activity\<2%;
• FⅧ inhibitor or FⅨ inhibitor titer in the screening period\>5 BU (Nijmegen modified Bethesda method of detection)."
• Age ≥18 and ≤65 years, male or female.
• There have been at least two incidents of bleeding of any kind in the last six months.
• No other drugs for the treatment of hemophilia have been used within 72hours (3 days) before administration, including prothrombin complex and any coagulation factor VII or activated coagulation factor VII、coagulation factor VIII、coagulation factor IX products, cryoprecipitate, fresh plasma and whole blood, etc.
• 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.

You may not qualify if:

• 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) within the past 1 year.
• Baseline and previous values of FⅦ inhibitor or activated recombinant human coagulation factor VII 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: glutamic-pyruvic transaminase (ALT) or aspartic transaminase (AST)\>2.5×ULN, or total bilirubin\>1.5×ULN or serum creatinine\>1.5×ULN.
• Severe heart disease, including myocardial infarction, cardiac insufficiency grade 3 or above, the current New York Heart Association cardiac function grade II-IV.
• There was a prior intracranial hemorrhage
• Those who had used or planned to use any anticoagulants, antifibrinants and drugs affecting platelet function during the first week of medication included non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin
• 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 Activated coagulation factor VII, coagulation factor VIII and coagulation factor IX trials) within one month before the first medication.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (9)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730013, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

Affiliated Hospital of North China University of Science and Technology

Tangshan, Hebei, 063099, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 463599, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

RECRUITING

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

RECRUITING

Hematology Hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Interventions

Injections

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Lei Zhang, Doctor

CONTACT

13502118379; zhanglei1@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: August 4, 2022
• Study Start: April 28, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

CN (9)