The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in patients with von Willebrand disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
SR604 will be administered as SC injection.
Xiangya Hospital of Central South University
Changsha, China
RECRUITINGThe First Affiliated Hospital of University of Science and Technology of China
Hefei, China
RECRUITINGTotal annualized bleeding rate (ABR) after treatment
Time frame: From baseline, through study completion, an average of 52 weeks
Annualized spontaneous bleeding rate
Time frame: From baseline, through study completion, an average of 52 weeks
Annualized traumatic bleeding rate
Time frame: From baseline, through study completion, an average of 52 weeks
Overall annualized bleeding rate, annualized spontaneous bleeding rate, and annualized traumatic bleeding rate
Time frame: From baseline, through study completion, an average of 52 weeks
EQ-5D-5L health questionnaire utility value
Time frame: From baseline, through study completion, an average of 52 weeks
Change in EQ-VAS score from baseline
Time frame: From baseline, through study completion, an average of 52 weeks
PK parameters after first dose:Peak Plasma Concentration (Cmax)
Time frame: Day1
Pharmacokinetic parameters after multiple doses: Peak Plasma Concentration (Cmax)
Time frame: From baseline, through study completion, an average of 52 weeks
Incidence of Adverse Events (AEs)
Number of participants experiencing at least one AE
Time frame: From baseline, through study completion, an average of 52 weeks
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Jinan Central Hospital
Jinan, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
RECRUITINGThe First Affiliated Hospital of Soochow University
Suzhou, China
RECRUITINGThe Second Hospital of Shanxi Medical University
Taiyuan, China
RECRUITINGNorth China University of Science and Technology Affiliated Hospital
Tangshan, China
RECRUITINGInstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China
RECRUITINGHenan Provincial People's Hospital
Zhengzhou, China
RECRUITINGPK parameters after first dose:Time to Peak Plasma Concentration (Tmax)
Time frame: Day1
Safety: Number and incidence of patients with anti-drug antibodies (ADA)
Time frame: From baseline, through study completion, an average of 52 weeks
Pharmacokinetic parameters after multiple doses: Time to Peak Plasma Concentration (Tmax)
Time frame: From baseline, through study completion, an average of 52 weeks
Incidence of Serious Adverse Events (SAEs)
Number of participants experiencing at least one SAE
Time frame: From baseline, through study completion, an average of 52 weeks
Incidence of Adverse Events of Special Interest (AESIs)
Number of participants experiencing at least one AESI
Time frame: From baseline, through study completion, an average of 52 weeks
Pharmacodynamic indicators:protein C
Time frame: From baseline, through study completion, an average of 52 weeks
Pharmacodynamic indicators:prothrombin time (PT)
Time frame: From baseline, through study completion, an average of 52 weeks
Pharmacokinetic parameters after multiple doses:Time to Peak Plasma Concentration (Tmax)
Time frame: From baseline, through study completion, an average of 52 weeks
Pharmacokinetic parameters after multiple doses: Area Under the Concentration-Time Curve from Zero to Last Quantifiable Time Point (AUC0-t)
Time frame: From baseline, through study completion, an average of 52 weeks