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ALN-6400 for Von Willebrand Disease and Heavy Menstrual Bleeding

(HMBeacon Trial)

AC
Overseen ByAlnylam Clinical Trial Information Line
Age: < 65
Sex: Female
Trial Phase: Phase 2
Sponsor: Alnylam Pharmaceuticals
Must not be taking: Routine factor prophylaxis
Disqualifiers: Liver disease, Kidney disease, Gynecological conditions, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Alnylam Pharmaceuticals

Are You a Good Fit for This Trial?

Inclusion Criteria

Inclusion Criteria -
I am a teen or adult with VWD and have had heavy menstrual bleeding for 2 cycles.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of ALN-6400

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ALN-6400

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: ALN-6400 (Treatment Group B)Experimental Treatment1 Intervention
Group II: ALN-6400 (Treatment Group A)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alnylam Pharmaceuticals

Lead Sponsor

Trials
81
Recruited
16,100+

Dr. Yvonne Greenstreet

Alnylam Pharmaceuticals

Chief Executive Officer since 2021

MD from the University of Leeds, MBA from INSEAD

Dr. Pushkal Garg

Alnylam Pharmaceuticals

Chief Medical Officer since 2016

MD from Columbia University

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