HMBeacon: A Phase 2, Randomized, Double-blind Study of the Safety, Tolerability, Efficacy, and Pharmacodynamics of Multiple Dose ALN-6400 in Female Patients with Von Willebrand Disease (VWD) and Heavy Menstrual Bleeding (HMB)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524967-19-00

Enrollment

Registered

2026-07-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

Frequency of AEs. Safety will also be evaluated through vital signs, ECGs, and clinical laboratory assessments.

Detailed description

- Change from baseline in PLG o Plasma activity levels o Plasma protein levels - Change from baseline in menstrual blood loss via PBAC - PRO scores o PGI-C o Change from baseline in PGI-S

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Frequency of AEs. Safety will also be evaluated through vital signs, ECGs, and clinical laboratory assessments.	—

Secondary

Measure	Time frame
- Change from baseline in PLG o Plasma activity levels o Plasma protein levels - Change from baseline in menstrual blood loss via PBAC - PRO scores o PGI-C o Change from baseline in PGI-S	—

Outcome results