- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04768699
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
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- 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
-
-
Tianjin
-
Tianjin, Tianjin, China, 300020
- Recruiting
- Hematology Hospital of Chinese Academy of Medical Sciences
-
Contact:
- Zhang Lei, Doctor
- Phone Number: +86-13502118379
- Email: zhanglei1@ihcams.ac.cn
-
-
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
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 |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TQG203(30µg/kg)
|
TQG203,30µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.
TQG203,180µg/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)
|
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.
|
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)
|
TQG203,30µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.
TQG203,180µg/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
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
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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
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.
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)
December 1, 2020
Primary Completion (ANTICIPATED)
December 1, 2021
Study Completion (ANTICIPATED)
December 1, 2021
Study Registration Dates
First Submitted
January 29, 2021
First Submitted That Met QC Criteria
February 22, 2021
First Posted (ACTUAL)
February 24, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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