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Tests treatment safety and results for Von Willebrand Disease (VWD)
Official title A Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of SR604 Injection in Patients With Von Willebrand Disease
ClinicalTrials.gov ID: NCT07640893
What this study is testing
What is SR604?
SR604 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for von willebrand disease (vwd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in patients with von Willebrand disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients must meet ALL of the following 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;
You likely can't join if
- Patients meeting ANY of the following exclusion criteria will not be enrolled:
- Known history of hypersensitivity to the investigational drug formulation or any of its components;
- Intolerance to subcutaneous injection or presence of other local skin abnormalities or dermatological conditions that may affect drug administration...
- Meeting any of the following criteria at screening:
- Hemoglobin \< 60 g/L;
- Platelet count \< 80 x 10\^9/L;
See the full eligibility criteria
- Patients must meet ALL of the following 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...
- Patients meeting ANY of the following exclusion criteria will not be enrolled:
- Known history of hypersensitivity to the investigational drug formulation or any of its components;
- Intolerance to subcutaneous injection or presence of other local skin abnormalities or dermatological conditions that may affect drug administration and safety assessment;
- Meeting any of the following criteria at screening:
- Hemoglobin \< 60 g/L;
- Platelet count \< 80 x 10\^9/L;
- Hepatic or renal dysfunction: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>= 2.5 x upper limit of normal (ULN), or total bilirubin \>= 1.5 x ULN; or serum creatinine (Cr) \>= 1.5 x ULN;
- Positive for anti-human immunodeficiency virus (HIV) antibody;
- Presence of any bleeding disorder other than von Willebrand disease [hemophilia A or B, congenital coagulation factor VII deficiency, acquired von Willebrand disease (AVWS), platelet-type VWD, inherited platelet...
- Presence of protein C deficiency or protein S deficiency;
- History of thrombosis or family history of thrombosis prior to signing informed consent or currently, or history of thrombophilia;
- Severe bleeding due to VWD within 2 years prior to screening, such as intracranial hemorrhage, esophageal variceal bleeding, etc.;
- Severe cardiac disease, such as unstable angina, congestive heart failure (New York Heart Association class \>= III), severe arrhythmia (QTc interval \> 500 ms, corrected by Fridericia formula), uncontrolled...
- Female patients with menstrual abnormalities due to organic gynecological diseases (e.g., uterine fibroids, endometriosis, adenomyosis, etc.);
- Previous or current life-threatening malignant neoplasms or end-stage liver disease;
- Use of DDAVP or plasma-derived VWF-containing factor VIII concentrate, plasma-derived/recombinant VWF preparations, or antifibrinolytic therapy within 1 week prior to the first dose;
- Use of antithrombotic agents within 1 week prior to the first dose;
- Receipt of fresh blood/plasma or cryoprecipitate therapy within 2 weeks prior to the first dose;
- Receipt of vaccination within 1 month prior to the first dose or planned vaccination during the study period;
- Major surgery (major surgery defined as Grade III and IV surgeries) within 1 month prior to the first dose, or planned surgery during the study period;
- Enrollment in other clinical trials within 1 month prior to the first dose;
- History of drug abuse or alcohol dependence (alcohol dependence criteria: long-term drinking history exceeding 5 years, equivalent ethanol intake \>= 40 g/day, or heavy drinking within 2 weeks, equivalent ethanol intake...
- Presence of psychiatric disease or significant mental disorder, or other reasons resulting in incapacity or lack of cognitive ability;
- Plans for procreation or sperm donation throughout the study period up to 3 months after the last dose, or unwillingness to use effective physical contraceptive measures (e.g., condoms);
- Presence of clinically significant disease or other reasons rendering the patient unsuitable for clinical trial participation in the investigator's opinion (e.g., patient unlikely to benefit from the clinical trial);
- Patients whom the investigator considers to have poor compliance, rendering how well it works evaluation difficult or likelihood of completing the planned treatment course and follow-up low.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, China
- Hefei, China
- Jinan, China
- Nanning, China
- Suzhou, China
- Taiyuan, China
- Tangshan, China
- Tianjin, China
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, China; Hefei, China; Jinan, China; Nanning, China; Suzhou, China; Taiyuan, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.