Clinical Trials in the Netherlands / NCT07575308
Recruiting
Phase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
NCT07575308 · tracked via the Priya Life Science Netherlands tracker
Condition(s) studied
Von Willebrand Disease (VWD)Heavy Menstrual Bleeding (HMB)
Investigational drug(s) / intervention(s)
ALN-6400: ALN-6400 will be administered subcutaneously (SC).
Study summary
The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacodynamics (PD) of multiple doses of ALN-6400 in adult and adolescent patients with VWD and HMB
Eligibility
Inclusion Criteria -
* Is an adolescent or adult patient with a diagnosis of VWD (including Type 1, Type 2, Type 3, and platelet-type VWD) and HMB for 2 cycles during screening
Exclusion Criteria -
* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times the upper limit of normal (ULN)
* Has total bilirubin greater than 1.5×ULN (except for patients with Gilbert's syndrome)
* Has an estimated glomerular filtration (eGFR) less than 30 mL/min/1.73m\^2 at screening
* Is not willing to comply with the contraceptive requirements during the study period
* Used routine factor prophylaxis (greater than or equal to 1 infusion of factor per week over 12 weeks) within 4 weeks of screening or plans use for routine factor prophylaxis during the study
* New placement of any hormonal or nonhormonal intrauterine device (IUD) or hormonal implants within 24 weeks of screening
* Known current gynecological conditions causing abnormal uterine bleeding (including infection, fibroids, endometriosis, polycystic ovary syndrome, or dysplasia)
Note: other protocol defined inclusion / exclusion criteria apply
Primary outcome measure(s)
- Frequency of Adverse Events — Up to Week 72
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinical Trial Site | Orange | California | Recruiting |
| Clinical Trial Site | San Diego | California | Recruiting |
| Clinical Trial Site | San Francisco | California | Recruiting |
| Clinical Trial Site | Miami | Florida | Recruiting |
| Clinical Trial Site | Lexington | Kentucky | Recruiting |
| Clinical Trial Site | Pittsburgh | Pennsylvania | Recruiting |
| Clinical Trial Site | Nijmegen | Netherlands | Not Yet Recruiting |
| Clinical Trial Site | Stockholm | Sweden | Not Yet Recruiting |
| Clinical Trial Site | Bradford | United Kingdom | Not Yet Recruiting |
| Clinical Trial Site | Oxford | United Kingdom | Not Yet Recruiting |
| Clinical Trial Site | Truro | United Kingdom | Not Yet Recruiting |
More Alnylam Pharmaceuticals trials in the Netherlands
A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07575308 on ClinicalTrials.gov ↗ ← All trials in the Netherlands