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

Part of paid clinical trials in Miami, Florida.

Sponsor
Alnylam Pharmaceuticals
Study ID
NCT07575308
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • ALN-6400 — DRUG
    ALN-6400 will be administered subcutaneously (SC).

Study Details

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

Key Dates

Start date
May 22, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Nov 29, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ALN-6400 (Treatment Group A)
    Participants will be administered multiple doses of ALN-6400.
  • Experimental: ALN-6400 (Treatment Group B)
    Participants will be administered multiple doses of ALN-6400.

Primary Outcome Measure

Frequency of Adverse Events [ Time Frame: Up to Week 72 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Trial SiteMiamiFlorida33024-

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