A Multi-Dose, Randomized, Multicenter Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of SR604 Injection in Patients With Von Willebrand Disease
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in patients with von Willebrand disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Patients must meet ALL of the following inclusion criteria to be enrolled:
‣ Age \>= 18 years and \<= 65 years at the time of signing informed consent, regardless of sex;
⁃ At screening, patients with a confirmed diagnosis of von Willebrand disease (VWD) with documented evidence and a defined VWD subtype;
⁃ At least 4 new bleeding episodes within 6 months prior to screening;
⁃ No active bleeding symptoms prior to the first dose;
⁃ The subject or impartial witness fully understands and is able to comply with the protocol requirements, is willing to complete the study as planned, and voluntarily agrees to provide biological samples for testing as required by the protocol; is able to understand the procedures and methods of this clinical trial, provides voluntary participation after full informed consent, and personally signs the informed consent form.
Locations
Other Locations
China
Xiangya Hospital of Central South University
RECRUITING
Changsha
The First Affiliated Hospital of University of Science and Technology of China
RECRUITING
Hefei
Jinan Central Hospital
RECRUITING
Jinan
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The Second Hospital of Shanxi Medical University
RECRUITING
Taiyuan
North China University of Science and Technology Affiliated Hospital
RECRUITING
Tangshan
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Research and Development
hanyu@raas-corp.com
862122130888
Time Frame
Start Date:2025-11-26
Estimated Completion Date:2027-12-31
Participants
Target number of participants:24
Treatments
Experimental: Multiple-dose exploratory efficacy trial consists of 4 cohorts
Participants with Von Willebrand Disease will receive SR604 dose 1 as multiple SC injections every 4-weeks, or dose 2 as multiple SC injections every 4-weeks/6-weeks/8-weeks.