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NCT07575308PHASE2Recruiting

HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB

Alnylam Pharmaceuticals

Start Date

7/30/2026

Completion Date

11/29/2028

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 Criteria

Age Range: 16 years to 45 years

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

Interventions

DRUG

ALN-6400

Interested in This Trial?

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Conditions

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

Locations

Clinical Trial Site

Orange, California 92868

United States

Clinical Trial Site

San Diego, California 92123

United States

Clinical Trial Site

San Francisco, California 94143

United States

Clinical Trial Site

Miami, Florida 33024

United States

Clinical Trial Site

Lexington, Kentucky 40536

United States

Clinical Trial Site

Pittsburgh, Pennsylvania 15213

United States

Clinical Trial Site

Nijmegen, 6525 GA

Netherlands

Clinical Trial Site

Stockholm, 171 76

Sweden

Clinical Trial Site

Bradford, BD9 6RJ

United Kingdom

Clinical Trial Site

Oxford, OX3 7HE

United Kingdom

Clinical Trial Site

Truro, TR1 3LJ

United Kingdom