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RecruitingPhase 2

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

Alnylam Pharmaceuticals · NCT07575308

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 16–45 · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
24
US sites recruiting
1
Study start
July 30, 2026
Record last updated
October 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: ALN-6400

Conditions: Von Willebrand Disease (VWD); Heavy Menstrual Bleeding (HMB)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • Alnylam Clinical Trial Information Line · 1-877-ALNYLAM · clinicaltrials@alnylam.com
  • Alnylam Clinical Trial Information Line · 1-877-256-9526 · clinicaltrials@alnylam.com
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HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and… (NCT07575308) | Bored Studies