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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
Phase
Phase 2
Started
2026-07-30
Last updated
2026-09-18

Condition(s) studied

Von Willebrand Disease (VWD)Heavy Menstrual Bleeding (HMB)

Investigational drug(s) / intervention(s)

ALN-6400 →

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

Sex
FEMALE
Min age
16 Years
Max age
45 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
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