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HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
RecruitingPhase 2
HMBeacon: A Phase 2, Randomized, Double-blind Study of the Safety, Tolerability, Efficacy, and Pharmacodynamics of Multiple Dose ALN-6400 in Adult and Adolescent Female Patients With Von Willebrand Disease (VWD) and Heavy Menstrual Bleeding (HMB)
Who can join
Ages 16 to 45 · Women
Full eligibility criteria
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
About the study
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
What is being tested
- ALN-6400 (drug)
Sponsor: Alnylam Pharmaceuticals · Participants: 24 · Started: Jul 30, 2026
Contact the study team
- Alnylam Clinical Trial Information Line · Phone: 1-877-ALNYLAM
- Alnylam Clinical Trial Information Line · Phone: 1-877-256-9526
Official record on ClinicalTrials.gov — NCT07575308
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.