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

February 22, 2021 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Dose-ascending Study to Evaluate the Pharmacokinetics and Pharmacodynamics (PK/PD) of Recombinant Human Coagulation Factor VIIa for Injection in Patients With Hemophilia.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: TQG203(30µg/kg)
Drug: 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.
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.
EXPERIMENTAL: TQG203(90µg/kg)
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.
ACTIVE_COMPARATOR: NovoSeven®(90µg/kg)
NovoSeven®,manufactured by Novo Nordisk Inc.
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.
EXPERIMENTAL: TQG203(180µg/kg)
Drug: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pharmacokinetic assessment, based on plasma concentration of Recombinant Human Coagulation Factor VIIa.
Time Frame: pre-dosing on Day 1 up to 24 hours post-dosing
pre-dosing on Day 1 up to 24 hours post-dosing
Pharmacodynamic assessment, based on changes of activated partial thromboplastin time (APTT).
Time Frame: pre-dosing on Day 1 up to 24 hours post-dosing
pre-dosing on Day 1 up to 24 hours post-dosing
Pharmacodynamic assessment, based on changes of prothrombin time (PT).
Time Frame: pre-dosing on Day 1 up to 24 hours post-dosing
pre-dosing on Day 1 up to 24 hours post-dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Immunogenicity assessment, based on inhibitors to Factor VIIa (FVIIa) or Factor VIII (FVIII) or Factor IX (FIX).
Time Frame: through study completion,an average of 1year.
through study completion,an average of 1year.
Adverse events
Time Frame: The presence of adverse events will be observed, reported and sufficiently handled during subjects' participation in the study.
The presence of adverse events will be observed, reported and sufficiently handled during subjects' participation in the study.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TQG203-I-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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