NCT07575308 HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
| NCT ID | NCT07575308 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Alnylam Pharmaceuticals |
| Condition | Von Willebrand Disease (VWD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-07-30 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2026-07-30 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Alnylam Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07575308 clinical trial?
This trial is open to female participants only, aged 16 Years or older, up to 45 Years, studying Von Willebrand Disease (VWD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07575308 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07575308 currently recruiting?
Yes, NCT07575308 is actively recruiting participants. Contact the research team at clinicaltrials@alnylam.com for enrollment information.
Where is the NCT07575308 trial being conducted?
This trial is being conducted at Los Angeles, United States, Orange, United States, Miami, United States, Lexington, United States.
Who is sponsoring the NCT07575308 clinical trial?
NCT07575308 is sponsored by Alnylam Pharmaceuticals. The principal investigator is Medical Director at Alnylam Pharmaceuticals. The trial plans to enroll 24 participants.