Actively Recruiting
Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein
Led by Jiangsu Gensciences lnc. · Updated on 2024-02-28
120
Participants Needed
28
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the prophylactic efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. To evaluate the safety of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. Secondary purpose: To evaluate the efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein for injection (FRSW117) in hemostasis and surgical hemostasis in patients with severe hemophilia A. To evaluate the pharmacokinetic (PK) characteristics of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A. To evaluate the immunogenicity of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.
CONDITIONS
Official Title
Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged between 12 and 65 years
- Clinically confirmed severe hemophilia A with factor VIII activity less than 1%
- Previous treatment with recombinant and/or blood-derived factor VIII products or cryoprecipitate with at least 150 exposure days
- Normal prothrombin time or INR less than 1.3
- Detailed record of bleeding events for at least 6 months before screening, with at least 6 spontaneous bleeding episodes in 6 months for on demand or prophylaxis participants
- Ability to understand the study and provide informed consent, with cooperation for home bleeding treatment and ability to complete all study procedures
You will not qualify if you...
- Known or suspected allergy to the study drug or its components, including mouse or hamster proteins
- Past hypersensitivity or anaphylaxis to factor VIII or IgG2 injections
- Positive factor VIII inhibitor test during screening or history/family history of factor VIII inhibitors
- Von Willebrand factor antigen below normal limits
- Severe anemia at screening (hemoglobin less than 60 g/L)
- Platelet count below 100 x 10^9/L during screening
- Abnormal liver function with ALT or AST more than 3 times upper limit or bilirubin over 1.5 times upper limit
- Abnormal kidney function with creatinine clearance below 50 ml/min or serum creatinine over 1.5 times upper limit
- Active hepatitis C infection, positive syphilis antibody, or HIV positive
- Other coagulation disorders besides hemophilia A
- Medical conditions increasing bleeding risk
- History of drug or alcohol abuse
- Mental disorders affecting study compliance
- Recent blood transfusions within 4 weeks before screening
- Participation in other clinical trials within 1 month before screening
- Use of anticoagulants, antiplatelet drugs, or off-label NSAIDs within 7 days before screening or planned during the study
- Severe cardiovascular or cerebrovascular diseases or major thromboembolic events
- Use of emesezumab within 6 months before first drug administration
- Use of monoclonal antibodies, Fc fusion proteins (except FRSW107 and FRSW117), PEG products (except FRSW117), or intravenous immunoglobulin within 3 months before first drug dose
- Major surgery within 3 months prior to first drug dose
- Use of standard or extended half-life factor VIII preparations within specified days before first dose
- Fever, active infection, or allergies within 2 weeks before first drug administration
- Use of systemic immunomodulators within 14 days before first dose except inhaled, nasal, or topical corticosteroids
- Vaccination within 4 weeks prior to first dose or planned during pharmacokinetic blood collection
- Planning pregnancy, sperm donation, or unwillingness to use effective contraception during the trial and 3 months after last dose
- Other serious medical conditions deemed unsuitable by investigators
- Subjects considered unsuitable by investigators for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Beijing tongren hospital,CMU
Beijing, China
Actively Recruiting
2
XiangYa Hospital CentralSouth University
Changsha, China
Actively Recruiting
3
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Not Yet Recruiting
4
Fujian Medical University Union Hospital
Fuzhou, China
Actively Recruiting
5
Nanfang Hospital of Southern Medical University
Guangzhou, China
Actively Recruiting
6
The First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
7
Anhui Provincial Hospital
Hefei, China
Actively Recruiting
8
Jinan central hospital
Jinan, China
Actively Recruiting
9
The First Affiliated Hospital of Shandong First Medical University
Jinan, China
Actively Recruiting
10
The Second Affiliated Hospital of Kunming Medical University
Kunming, China
Actively Recruiting
11
The First Hospital of Lanzhou University
Lanzhou, China
Actively Recruiting
12
Jiangxi Provincial People's Hospital
Nanchang, China
Actively Recruiting
13
Nanjing Drum Tower Hospital
Nanjing, China
Not Yet Recruiting
14
Affiliated Hospital of Nantong University
Nantong, China
Actively Recruiting
15
The Affiliated Hospital of Qingdao University
Qingdao, China
Not Yet Recruiting
16
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, China
Not Yet Recruiting
17
Shenzhen Second People's Hospital
Shenzhen, China
Actively Recruiting
18
The First Affiliated Hospital of Soochow University
Suzhou, China
Actively Recruiting
19
The Second Hospital of Shanxi Medical University
Taiyuan, China
Actively Recruiting
20
North China University of Science and Technology Affiliated Hospital
Tangshan, China
Actively Recruiting
21
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, China
Actively Recruiting
22
Affiliated Hospital of Jiangnan University
Wuxi, China
Actively Recruiting
23
The First Affiliated Hospital of Xiamen University
Xiamen, China
Actively Recruiting
24
Zhenyu Li
Xuzhou, China
Not Yet Recruiting
25
Subei People's Hospital of Jiangsu province
Yangzhou, China
Actively Recruiting
26
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
27
Henan Provincial People's Hospital
Zhengzhou, China
Not Yet Recruiting
28
Zhengzhou People's Hospital
Zhengzhou, China
Not Yet Recruiting
Research Team
C
Chen Ling
CONTACT
R
Renchi Yang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here