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.
NCT ID: NCT04456387
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
119 participants
INTERVENTIONAL
2020-10-15
2021-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1-on demand treatment
Part A-Participants will receive on-demand treatment with Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection for 6 months.
Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Participants received on-demand treatment, doses range from 30 IU/kg to 50 IU/kg, or doses divided on the discretion of the Investigator.
Arm 2- prophylaxis treatment
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.
Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Participants received prophylaxis treatment at 50 IU/kg every three days.
Interventions
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Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
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 Injection
Participants received prophylaxis treatment at 50 IU/kg every three days.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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).
Exclusion Criteria
* 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).
* 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.
12 Years
60 Years
MALE
No
Sponsors
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Zhengzhou Gensciences Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Renchi Yang, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Capital Medical University affiliated Beijing Children's Hospital
Beijing, Beijing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Henan provincial People's Hospital
Zhengzhou, He'nan, China
Henan Cancer Hospital
Zhengzhou, He'nan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Jinan central hospital
Ji'nan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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CTR20201212
Identifier Type: -
Identifier Source: org_study_id