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

August 2, 2022 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Phase III Clinical Study of the Efficacy and Safety of Recombinant Human Activated Coagulation Factor VII for Injection in Patients With Hemophilia With Inhibitors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730013
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Hebei
      • Tangshan, Hebei, China, 063099
        • Recruiting
        • Affiliated Hospital of North China University of Science and Technology
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 463599
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • Jiangxi Provincial People's Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Recruiting
        • Hematology Hospital of Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1 Diagnosed as congenital hemophilia A or B, and meet the following conditions:

    1. FⅧ<1% or FIX activity<2%;
    2. FⅧ inhibitor or FⅨ inhibitor titer in the screening period>5 BU (Nijmegen modified Bethesda method of detection)."
  • 2 Age ≥18 and ≤65 years, male or female.
  • 3 There have been at least two incidents of bleeding of any kind in the last six months.
  • 4 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.
  • 5 Subjects of childbearing age agree to take effective contraceptive measures throughout the trial period, and continue to 28 days after the last medication.
  • 6 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:

  • 1 Any other bleeding disease except Congenital hemophilia A or B.
  • 2 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.
  • 3 Baseline and previous values of FⅦ inhibitor or activated recombinant human coagulation factor VII inhibitor is positive.
  • 4 Vitamin K deficiency.
  • 5 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.
  • 6 Subjects plan to perform elective surgery during the trial period.
  • 7 Those who are allergic to test drugs or any excipients.
  • 8 Severe anemia and need blood transfusion.
  • 9 Platelet count <80×10^9/L.
  • 10 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.
  • 11 Severe heart disease, including myocardial infarction, cardiac insufficiency grade 3 or above, the current New York Heart Association cardiac function grade II-IV.
  • 12 There was a prior intracranial hemorrhage
  • 13 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
  • 14 Hypertension that cannot be controlled with drug treatment: systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg.
  • 15 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.
  • 16 Alcoholism, drug abuse, mental disorders, other severe acute or chronic diseases, greater abnormal laboratory values, and those who are considered unsuitable by the researcher.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recombinant human activated coagulation factor VII for injection
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of bleeding Effective rate of hemostasis
Time Frame: Each new blood event was assessed within 12 hours of initial treatment
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
Time Frame: Within 1 hour of completion of infusion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of bleeding effective rate of hemostasis within 8 hours
Time Frame: Each new blood event was assessed within 8 hours of initial treatment
Excellent remission (based on the four-point scoring standard)
Each new blood event was assessed within 8 hours of initial treatment
Number of bleeding effective rate continuous hemostatic
Time Frame: Each new blood event was assessed within 24 hours of initial treatment
Moderate or above remission (based on grade 4 scoring criteria) without receiving other treatment within 24 hours after the occurrence of bleeding event is considered as effective hemostasis after the occurrence of bleeding event.
Each new blood event was assessed within 24 hours of initial treatment
Activity recovery after repeated administration
Time Frame: Within 1 hour of completion of infusion
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
Dose of injections for each new blood transfusion
Time Frame: Up to 24 weeks.
Dose of injections for each new blood transfusion.The dose of injections (including average injection dose and total dose) of each new blood transfusion were recorded.
Up to 24 weeks.
Number of injections for each new blood transfusion
Time Frame: Up to 24 weeks.
Number of injections for each new blood transfusion.The number of injections of each new blood transfusion were recorded.
Up to 24 weeks.
Coagulation tests
Time Frame: First and week 24, within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation tests: Changes of activated partial thromboplastin time (APTT).
First and week 24, within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation tests
Time Frame: First and week 24, within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation indicators: Changes of prothrombin time (PT).
First and week 24, within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation tests
Time Frame: First and week 24, within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation indicators: Changes of thrombin time(TT).
First and week 24, within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation tests
Time Frame: First and week 24, within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation indicators: Changes of fibrinogen (Fbg).
First and week 24, within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation tests
Time Frame: First and week 24，within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation indicators: thrombin production test (TGA):Changes of thrombin production potential (ETP) in TGA at each test time.
First and week 24，within 30 minutes before the administration and 5 minutes after the completion of drug injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQG203-III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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