A Study of Bleeding and Treatment in Participants With Von Willebrand Disease

Launched by HEMAB APS · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying bleeding events and treatment experiences in people with Von Willebrand Disease (VWD), a condition that affects blood clotting. The goal is to gather information on how often bleeding occurs, how it impacts daily life, and the overall effects of VWD on patients. This information will help establish a baseline for future studies and improve understanding of the condition.

To be eligible for the study, participants need to be at least 16 years old and have a confirmed diagnosis of one of the types of VWD, showing specific blood test results indicating their condition. Those who join the study will share their experiences with bleeding and treatment, helping researchers learn more about VWD. It's important to note that individuals with certain medical histories or conditions that could affect bleeding symptoms won't be able to participate. If you or a family member experience regular bleeding or bruising due to VWD, this study could be a valuable way to contribute to future advancements in treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Has the ability to provide informed consent to participate in the study, in accordance with applicable regulations.
• • 2. Has an understanding, ability, and willingness to comply with Study procedures and restrictions.
• • 3. ≥ 16 years at the time of screening.
• • 4. Has congenital Type 1 VWD with a residual VWF antigen and/or activity \<30 IU/dL and/or meets the bleeding event rate inclusion criteria. Other congenital VWD subtypes may be enrolled with Sponsor approval.
• • 5. Has symptomatic disease as defined by a history of bruising or bleeding events, with an expected minimum of 3 bleeding episodes (including heavy menstrual bleeding) per year that require treatment to control bleeding symptoms, and/or has recurrent and ongoing episodes of heavy menstrual bleeding at the time of enrollment.
• Exclusion Criteria:
• • 1. Has a personal history of venous or arterial thrombosis or thromboembolic disease, except for catheter-associated, superficial vein thrombosis events.
• • 2. Has a significant family history of unprovoked thromboembolic events in first degree relatives.
• • 3. Has a congenital or acquired bleeding disorder other than VWD.
• • 4. Has planned major surgery within the next 6 months.
• • 5. Is pregnant or plans to become pregnant within the next 6 months.
• • 6. Has any concurrent disease, treatment (including ongoing anticoagulation, antiplatelet, or non-steroidal anti-inflammatory drugs), condition, medication, or abnormality in clinical laboratory tests which may impact on the participant's bleeding symptoms or affect their ability to complete the study, in the Investigator's opinion.
• • 7. Has received any investigational product within 30 days prior to screening. If the participant was enrolled and dosed in Velora Pioneer (study HMB-002-102; NCT06754852), they must have completed their End of Study Visit.