Hemophilia APhase 3NCT04456387
An Open Label Study to Determine the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A.
A Phase 3 study testing Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in people with Hemophilia A, run by Zhengzhou Gensciences Inc at 17 sites in China.
Trial summary
The primary objectives of the study are to evaluate the efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in the Prevention and Treatment of Bleeding in patients with hemophilia A. Read more about this study
- Who is it for?
- Ages 12 to 60 years, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 17 sitesChina
- Study dates
- 15 Oct 2020to 30 Sep 2021
- 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 12 to 60 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1)Male, aged 12 to 60 years
- 2)Severe hemophilia A. The activity of the coagulation factor VIII (FVIII:C) < 1%, and previously treated with FVIII concentrate (s) for a minimum of 150 exposure days (EDs) prior to study entry.
- 3) No history of a positive inhibitor test (< 0.6 BU) or clinical signs of decreased response to FVIII administrations within 2 years before the test or during the screening period. No Family history of inhibitors.
- 4) Non-immune deficiency, with a certain immune capacity (CD4 > 200/μL)
- 5) Platelet count > 100,000 platelets/μL.
- 6) Normal prothrombin time or INR < 1.3.
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- 7) Normal previous results of vWF antigen examination.
- 8) Negative lupus anticoagulant.
- 9) the patient has a detailed record of bleeding events for at least 6 months (the subject can be admitted to the on-demand treatment group with spontaneous bleeding ≥3 times within 6 months).
- 10) Capable of understanding and willing to comply with the conditions of the protocol have read (patient and/or guardian).
Who cannot join
- 1) Hypersensitive to any of the excipients of the test materials (e.g. allergic to murine or hamster origin heterologous proteins).
- 2) History of hypersensitivity or anaphylaxis associated with any FVIII or II immunoglobulin administration.
- 3) Other coagulation disorder(s) in addition to hemophilia A.
- 4) Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level).
- 5) Clinically significant of other systematic diseases: alcoholism, drug abuse, mental disorders and mental retardation.
- 6) Significant hepatic or renal impairment (ALT and AST > 2×ULN; serum bilirubin level > 3 × upper limit of normal (ULN), BUN > 2×ULN, Cr > 176.8µmol/L).
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- 7) Patients who received any anticoagulant or antiplatelet therapy within one week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials.
- 8) Patients having major surgery or receiving blood or blood components transfusion within 4 weeks prior screening or having planned major surgery schedule during the study.
- 9) Patients who previously participated in the other clinical trials within 1 month prior screening.
- 10) One or more clinically significant tests for Hepatitis B Virus Surface Antigen, Human Immunodeficiency Virus (HIV), Antisyphilitic spirulina (TPHA) and Hepatitis C Virus (HCV) Antibody.
- 11) Any life-threatening disease or condition which, according to the investigator's judgment, could not benefit from the trial participation.
- 12) Patient who is considered by the other investigators not suitable for clinical study.
- NOTE:Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Capital Medical University affiliated Beijing Children's Hospital
Beijing, Beijing Municipality, 100045
Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404000
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Nanfang Hospital of Southern Medical University
Guangzhou, Guangzhou, 510515
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Anhui Provincial Hospital
Hefei, Anhui, 230001
Jinan central hospital
Ji'nan, Shandong, 250013
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, 300020
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221000
Henan provincial People's Hospital
Zhengzhou, He'nan, 450003
Henan Cancer Hospital
Zhengzhou, He'nan, 450008
About this study
Official title: An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in Adolescent and Adult Patients With Hemophilia A.
The primary objectives of the study are to evaluate the efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in the Prevention and Treatment of Bleeding in patients with hemophilia A.
The secondary objectives are to evaluate the efficacy and safety of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in the prevention and treatment of bleeding episodes, to investigate the quality of life in patients who used the FRSW107.
- Conditions
- Hemophilia A
- Being tested
- Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
- Keywords
- Hemophilia A, Efficacy and Safety, Factor VIII-Fc Fusion Protein, Adolescent and Adult Patients, Phase III, Pharmacokinetics
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for InjectionDrug
Participants received on-demand treatment, doses range from 30 IU/kg to 50 IU/kg, or doses divided on the discretion of the Investigator.
Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for InjectionDrug
Participants received prophylaxis treatment at 50 IU/kg every three days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1-on demand treatment | Experimental | Part A-Participants will receive on-demand treatment with Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection for 6 months. Receives: Drug: Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection |
| Arm 2- prophylaxis treatment | Experimental | Part B-Participants will receive prophylaxis treatment with Recombinant Human Coagulation Factor VIII-Fc fusion for 6 months.
12 Participants of them will receive PK assessment at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.)，measured by one-stage assay, they would not be given prophylaxis treatment until the completion of PK blood collection. Receives: Drug: Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A - score of bleeding symptoms and Vital signs.
Response to treatment with rFVIIIFc for bleeding episodes, using the 4-point bleeding response scale.
Measured: For the duration of study participation, 6 months.
Part B- Annualized Bleeding Rates(ABR).
Annualized bleeding rate = (number of bleeding episodes during the efficacy, period/total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of FRSW107 and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.
Measured: For the duration of study participation, 6 months.
Part B-Number of target joints.
The joint with ≥3 times of spontaneous bleeding in 6 consecutive months is the target joint, while the joint with < 2 times of bleeding in 12 consecutive months is no longer the target joint.
Measured: For the duration of study participation, 6 months.
Secondary outcomes (16)
Part A-rFVIIIFc incremental recovery (IR).
Incremental recovery of Factor VIII (FVIII) within 1 hour after end of infusions was determined and mean recovery values were reported.
Measured: For the duration of study participation, 6 months.
Part A -Total Dose Required for Resolution of a Bleeding Episode.
The total dose required to resolve a bleeding episode per participant, based on the efficacy period. The efficacy period begins with the first dose and ends with the last dose (for a bleed). For 'Per bleeding episode' values, for each bleeding episode, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. For 'Per participant' values, the total dose (IU/kg) used to resolve each bleed is averaged across all bleeding episodes per participant.Quality of life assessment.
Measured: For the duration of study participation, 6 months.
Part A -Number of injections required to resolve a bleeding episode.
The number of injections required to resolve a bleeding episode per participant, based on the efficacy period. The efficacy period begins with the first dose and ends with the last dose (for a bleed). All injections given from the initial sign of a bleed, until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed. For 'Per participant' values, the number of injections required to resolve each bleed is averaged across all bleeding episodes per participant.
Measured: For the duration of study participation, 6 months.
Part A -Quality of life assessment.
Quality of life assessment by Haemophilia Joint Health Score（HJHS）.
Measured: For the duration of study participation, 6 months.
Part B -Number of injections required to resolve a bleeding episode.
The number of injections required to resolve a bleeding episode per participant, based on the efficacy period. The efficacy period begins with the first prophylactic dose and ends with the last dose (for prophylaxis or a bleed). All injections given from the initial sign of a bleed, until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed. For 'Per participant' values, the number of injections required to resolve each bleed is averaged across all bleeding episodes per participant.
Measured: For the duration of study participation, 6 months.
Part B -Quality of life assessment.
Quality of life assessment by Haemophilia Joint Health Score(HJHS).
Measured: For the duration of study participation, 6 months.
Part B -Number of participants with inhibitor development
Number of participants who developed a positive FVIII inhibitor level (≥0.6 Bethesda unit [BU]) during the study was summarized and classified as participants developing low titer inhibitor (i.e. ≤ 5.0 BU) and participants developing high titer inhibitor (i.e. > 5.0 BU).
Measured: 6 months and at least 50 exposure days.
Part B - Number of Participants With Incidence of Antibody Formation to CHINESE HAMSTER OVARY (CHO).
A test to analyze the formation of antibodies to CHO.
Measured: before and the duration of study participation, 6 months.
Part B -Number of All Bleeds.
The annualized number of bleeds experienced by participants.
Measured: before and the duration of study participation, 6 months.
Part B-Maximum Activity (Cmax) as Measured by the aPTT Clotting Assay
Maximum measured concentration of rFVIIIFc.
Measured: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Part B-Half-life (t½) as Measured by aPTT Clotting Assay
Time required for the concentration of the drug to reach half of its original value.
Measured: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Part B-Clearance (CL) as Measured by the aPTT Clotting Assay
The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.
Measured: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Part B-Volume of Distribution at Steady State (Vss) as Measured by the aPTT Clotting Assay.
The apparent volume of distribution at steady state. (Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.).
Measured: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Part B-Mean Residence Time (MRT) as Measured by the aPTT Clotting Assay.
The average time at which the number of absorbed molecules reside in the body, after single-dose administration.
Measured: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Part B-Time of Cmax (Tmax) as Measured by aPTT Clotting Assay.
Time at which maximum activity (Cmax) is observed.
Measured: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Part B-Area Under the Curve to the Last Measurable Time Point (AUClast) as Measured by aPTT Clotting Assay.
Area under the plasma concentration time-curve from zero to the last measured concentration.
Measured: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start15 Oct 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengzhou Gensciences Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renchi Yang, PhD, Principal investigator, Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456387
- Sponsor's protocol ID
- CTR20201212
- Status last verified
- Oct 2020
- First submitted
- 22 Jun 2020
- Last updated
- 13 Dec 2023
- 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in Adolescent and Adult Patients With Hemophilia A.
- ClinicalTrials.gov ID
- NCT04456387
- Acronym / sponsor ID
- CTR20201212
- Conditions
- Hemophilia A
- Keywords
- Hemophilia A, Efficacy and Safety, Factor VIII-Fc Fusion Protein, Adolescent and Adult Patients, Phase III, Pharmacokinetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Zhengzhou Gensciences IncIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 2 Jul 2020 (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.
The primary objectives of the study are to evaluate the efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in the Prevention and Treatment of Bleeding in patients with hemophilia A.
The secondary objectives are to evaluate the efficacy and safety of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in the prevention and treatment of bleeding episodes, to investigate the quality of life in patients who used the FRSW107.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1-on demand treatment | Experimental | Drug: Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for InjectionPart A-Participants will receive on-demand treatment with Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection for 6 months. |
| Arm 2- prophylaxis treatment | Experimental | Drug: Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for InjectionPart B-Participants will receive prophylaxis treatment with Recombinant Human Coagulation Factor VIII-Fc fusion for 6 months. 12 Participants of them will receive PK assessment at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.)，measured by one-stage assay, they would not be given prophylaxis treatment until the completion of PK blood collection. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 1)Male, aged 12 to 60 years
- 2)Severe hemophilia A. The activity of the coagulation factor VIII (FVIII:C) < 1%, and previously treated with FVIII concentrate (s) for a minimum of 150 exposure days (EDs) prior to study entry.
- 3) No history of a positive inhibitor test (< 0.6 BU) or clinical signs of decreased response to FVIII administrations within 2 years before the test or during the screening period. No Family history of inhibitors.
- 4) Non-immune deficiency, with a certain immune capacity (CD4 > 200/μL)
- 5) Platelet count > 100,000 platelets/μL.
Key exclusion criteria (13 listed)
- 1) Hypersensitive to any of the excipients of the test materials (e.g. allergic to murine or hamster origin heterologous proteins).
- 2) History of hypersensitivity or anaphylaxis associated with any FVIII or II immunoglobulin administration.
- 3) Other coagulation disorder(s) in addition to hemophilia A.
- 4) Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level).
- 5) Clinically significant of other systematic diseases: alcoholism, drug abuse, mental disorders and mental retardation.
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 Coagulation Factor VIII-Fc Fusion Protein for InjectionParticipants received on-demand treatment, doses range from 30 IU/kg to 50 IU/kg, or doses divided on the discretion of the Investigator. | Drug | Arm 1-on demand treatment |
| Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for InjectionParticipants received prophylaxis treatment at 50 IU/kg every three days. | Drug | Arm 2- prophylaxis treatment |
Primary outcome
Part A - score of bleeding symptoms and Vital signs.
Time frame: For the duration of study participation, 6 months.
Response to treatment with rFVIIIFc for bleeding episodes, using the 4-point bleeding response scale.
Part B- Annualized Bleeding Rates(ABR).
Time frame: For the duration of study participation, 6 months.
Annualized bleeding rate = (number of bleeding episodes during the efficacy, period/total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of FRSW107 and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.
Part B-Number of target joints.
Time frame: For the duration of study participation, 6 months.
The joint with ≥3 times of spontaneous bleeding in 6 consecutive months is the target joint, while the joint with < 2 times of bleeding in 12 consecutive months is no longer the target joint.
16 secondary outcomes
Part A-rFVIIIFc incremental recovery (IR).
Time frame: For the duration of study participation, 6 months.
Part A -Total Dose Required for Resolution of a Bleeding Episode.
Time frame: For the duration of study participation, 6 months.
Part A -Number of injections required to resolve a bleeding episode.
Time frame: For the duration of study participation, 6 months.
Part A -Quality of life assessment.
Time frame: For the duration of study participation, 6 months.
Part B -Number of injections required to resolve a bleeding episode.
Time frame: For the duration of study participation, 6 months.
Part B -Quality of life assessment.
Time frame: For the duration of study participation, 6 months.
Part B -Number of participants with inhibitor development
Time frame: 6 months and at least 50 exposure days.
Part B - Number of Participants With Incidence of Antibody Formation to CHINESE HAMSTER OVARY (CHO).
Time frame: before and the duration of study participation, 6 months.
Part B -Number of All Bleeds.
Time frame: before and the duration of study participation, 6 months.
Part B-Maximum Activity (Cmax) as Measured by the aPTT Clotting Assay
Time frame: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Part B-Half-life (t½) as Measured by aPTT Clotting Assay
Time frame: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Part B-Clearance (CL) as Measured by the aPTT Clotting Assay
Time frame: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Part B-Volume of Distribution at Steady State (Vss) as Measured by the aPTT Clotting Assay.
Time frame: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Part B-Mean Residence Time (MRT) as Measured by the aPTT Clotting Assay.
Time frame: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Part B-Time of Cmax (Tmax) as Measured by aPTT Clotting Assay.
Time frame: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Part B-Area Under the Curve to the Last Measurable Time Point (AUClast) as Measured by aPTT Clotting Assay.
Time frame: Samples taken at pre-injection, and post dose up to 96 hours at ED1 and ED35(Participants will be tested for PK assessment at timepoints throughout the study based on exposure days (ED). One ED is equivalent to a 24 hours period in which drug is dosed.).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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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.
Renchi Yang, PhD principal investigator
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
17 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 Coagulation Factor VIII-Fc Fusion Protein for Injection in people with Hemophilia A, run by Zhengzhou Gensciences Inc at 17 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 10 inclusion and 13 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: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A - score of bleeding symptoms and Vital signs. (time frame: For the duration of study participation, 6 months.). 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 13 Dec 2023.