Hemophilia A With InhibitorPhase 1NCT04768699
Study of Recombinant Human Coagulation Factor VIIa for Injection (FⅦa) in Patients With Hemophilia.
A Phase 1 study testing TQG203 and TQG203/NovoSeven® in people with Hemophilia A With Inhibitor and Hemophilia B With Inhibitor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
- What is being tested?
- TQG203 and TQG203/NovoSeven®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Zhang Lei, Doctor, +86-13502118379, zhanglei1@ihcams.ac.cn
About this study
Official title: 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.
- Being tested
- TQG203, TQG203/NovoSeven®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQG203Drug
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/NovoSeven®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.
TQG203Drug
TQG203,180µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.
| Study group | Role | What they receive |
|---|---|---|
| TQG203(30µg/kg) | Experimental | Not described Receives: Drug: TQG203 |
| TQG203(90µg/kg) | Experimental | Not described Receives: Drug: TQG203/NovoSeven® |
| NovoSeven®(90µg/kg) | Active comparator | NovoSeven®,manufactured by Novo Nordisk Inc. Receives: Drug: TQG203/NovoSeven® |
| TQG203(180µg/kg) | Experimental | Not described Receives: Drug: TQG203 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic assessment, based on plasma concentration of Recombinant Human Coagulation Factor VIIa.
Measured: pre-dosing on Day 1 up to 24 hours post-dosing
Pharmacodynamic assessment, based on changes of activated partial thromboplastin time (APTT).
Measured: pre-dosing on Day 1 up to 24 hours post-dosing
Pharmacodynamic assessment, based on changes of prothrombin time (PT).
Measured: pre-dosing on Day 1 up to 24 hours post-dosing
Secondary outcomes (2)
Immunogenicity assessment, based on inhibitors to Factor VIIa (FVIIa) or Factor VIII (FVIII) or Factor IX (FIX).
Measured: through study completion,an average of 1year.
Adverse events
Measured: The presence of adverse events will be observed, reported and sufficiently handled during subjects' participation in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia A With InhibitorStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768699
- Sponsor's protocol ID
- TQG203-I-01
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-ascending Study to Evaluate the Pharmacokinetics and Pharmacodynamics (PK/PD) of Recombinant Human Coagulation Factor VIIa for Injection in Patients With Hemophilia.
- ClinicalTrials.gov ID
- NCT04768699
- Acronym / sponsor ID
- TQG203-I-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TQG203(30µg/kg) | Experimental | Drug: TQG203 |
| TQG203(90µg/kg) | Experimental | Drug: TQG203/NovoSeven® |
| NovoSeven®(90µg/kg) | Active comparator | Drug: TQG203/NovoSeven®NovoSeven®,manufactured by Novo Nordisk Inc. |
| TQG203(180µg/kg) | Experimental | Drug: TQG203 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQG203TQG203,30µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once. | Drug | TQG203(30µg/kg) |
| 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. | Drug | NovoSeven®(90µg/kg), TQG203(90µg/kg) |
| TQG203TQG203,180µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once. | Drug | TQG203(180µg/kg) |
Primary outcome
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
Pharmacodynamic assessment, based on changes of activated partial thromboplastin time (APTT).
Time frame: 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
2 secondary outcomes
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.
Adverse events
Time frame: The presence of adverse events will be observed, reported and sufficiently handled during subjects' participation in the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQG203 and TQG203/NovoSeven® in people with Hemophilia A With Inhibitor and Hemophilia B With Inhibitor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Zhang, Doctor (13502118379, zhanglei1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.