Hemophilia APhase 3NCT05487976
Clinical Study of Recombinant Human Activated Coagulation Factor VII for Injection in Patients With Hemophilia With Inhibitor
A Phase 3 study testing Recombinant human activated coagulation factor VII for injection in people with Hemophilia A and Hemophilia B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemophilia A, Hemophilia B
- What is being tested?
- Recombinant human activated coagulation factor VII for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesChina
- Study dates
- 28 Apr 2022to Apr 2023
- Phase
- Phase 3
- 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
- 1 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)."
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Xielan Zhao, Doctor, 13707489198, zhaoxl9198@163.com
Jie Peng, Doctor, 13974802938, pengjie-0728@163.com
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Shu Chen, Master, 13983420188, chenshu921@163.com
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Jing Sun, Doctor, 13316202696, jsun-cn@qq.com
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730013
Yaming Xi, Doctor, 13919110815, xiyaming02@163.com
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Chenghao Jin, Doctor, 13699500207, Jinch227@aliyun.com
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Peng Cheng, Master, 13977166448, 13977166448@163.com
- Recruiting
Affiliated Hospital of North China University of Science and Technology
Tangshan, Hebei, 063099
Zhenyu Yan, Doctor, 15931508262, hbyzy2011@163.com
- Recruiting
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Lei Zhang, 13502118379, zhanglei1@ihcams.ac.cn
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 463599
Pingchong Lei, Doctor, 13592605993, leipc5823@163.com
About this study
Official title: 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.
- Conditions
- Hemophilia A, Hemophilia B
- Being tested
- Recombinant human activated coagulation factor VII for injection
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human activated coagulation factor VII for injectionDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Recombinant human activated coagulation factor VII for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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].
Measured: Within 1 hour of completion of infusion
Secondary outcomes (10)
Number of bleeding effective rate of hemostasis within 8 hours
Excellent remission (based on the four-point scoring standard)
Measured: Each new blood event was assessed within 8 hours of initial treatment
Number of bleeding effective rate continuous hemostatic
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.
Measured: Each new blood event was assessed within 24 hours of initial treatment
Activity recovery after repeated administration
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].
Measured: Within 1 hour of completion of infusion
Dose of injections for each new blood transfusion
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.
Measured: Up to 24 weeks.
Number of injections for each new blood transfusion
Number of injections for each new blood transfusion.The number of injections of each new blood transfusion were recorded.
Measured: Up to 24 weeks.
Coagulation tests
Coagulation tests: Changes of activated partial thromboplastin time (APTT).
Measured: First and week 24, within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation tests
Coagulation indicators: Changes of prothrombin time (PT).
Measured: First and week 24, within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation tests
Coagulation indicators: Changes of thrombin time(TT).
Measured: First and week 24, within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation tests
Coagulation indicators: Changes of fibrinogen (Fbg).
Measured: First and week 24, within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Coagulation tests
Coagulation indicators: thrombin production test (TGA):Changes of thrombin production potential (ETP) in TGA at each test time.
Measured: First and week 24，within 30 minutes before the administration and 5 minutes after the completion of drug injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start28 Apr 2022
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT05487976
- Sponsor's protocol ID
- TQG203-III-01
- Status last verified
- Aug 2022
- First submitted
- 11 Apr 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05487976
- Acronym / sponsor ID
- TQG203-III-01
- Conditions
- Hemophilia A, Hemophilia B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 4 Aug 2022 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant human activated coagulation factor VII for injection | Experimental | Drug: Recombinant human activated coagulation factor VII for injectionEach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1 Diagnosed as congenital hemophilia A or B, and meet the following conditions:
- 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.
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| Recombinant human activated coagulation factor VII for injectionHuman 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. | Drug | Recombinant human activated coagulation factor VII for injection |
Primary outcome
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)
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].
10 secondary outcomes
Number of bleeding effective rate of hemostasis within 8 hours
Time frame: 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
Activity recovery after repeated administration
Time frame: Within 1 hour of completion of infusion
Dose of injections for each new blood transfusion
Time frame: Up to 24 weeks.
Number of injections for each new blood transfusion
Time frame: 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
Time frame: 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 tests
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant human activated coagulation factor VII for injection in people with Hemophilia A and Hemophilia B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 sites 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 8 inclusion and 16 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 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of bleeding Effective rate of hemostasis (time frame: Each new blood event was assessed within 12 hours of initial treatment). The study lists 2 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 4 Aug 2022.