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Phase 2 Study of ALN-6400 for Von Willebrand Disease and Heavy Menstrual Bleeding

This study is testing a drug called ALN-6400 to see how safe and effective it is for adult and adolescent women who have Von Willebrand Disease (VWD), a bleeding disorder, and also experience heavy menstrual bleeding (HMB). ALN-6400 will be given as shots under the skin. The main goal is to track any side effects over about 1.5 years. You may be able to join if you are a woman between 16 and 45 years old, have a diagnosis of VWD (any type) and have had heavy menstrual bleeding for at least two cycles recently. We are looking to enroll 24 participants. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 24 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for up to 72 weeks (about 1.5 years).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07575308

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

Recruiting
PHASE2Ages 16–45InterventionalTreatment
Alnylam Pharmaceuticals
~24 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:ALN-6400

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of Adverse Events
Measured over Up to Week 72

Conditions

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

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NCT07575308

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Clinical Trial Site

    Los Angeles, Californiano site contact published

    Recruiting

  • Clinical Trial Site

    Orange, Californiano site contact published

    Recruiting

  • Clinical Trial Site

    Miami, Floridano site contact published

    Recruiting

  • Clinical Trial Site

    Lexington, Kentuckyno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Alnylam Pharmaceuticals

Who to contact

Alnylam Clinical Trial Information Line
[email protected]
1-877-ALNYLAM
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Frequency of Adverse EventsUp to Week 72