ALN-6400 for women with von Willebrand disease and heavy menstrual bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial evaluates the safety, tolerability, efficacy, and pharmacodynamics of multiple doses of ALN-6400 in adult and adolescent patients who have von Willebrand disease and heavy menstrual bleeding. Participants will receive ALN-6400 and be monitored for changes in bleeding and relevant biomarkers. The study includes specific eligibility criteria and excludes individuals with certain liver, kidney, or gynecologic conditions, as well as those with recent routine factor prophylaxis or unmet contraception requirements. Sites are located in Orange, San Diego, and San Francisco, California, with Alnylam Pharmaceuticals as the lead sponsor.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical Trial Site
  Miami, Florida, United States Recruiting
• Clinical Trial Site
  Orange, California, United States Not yet recruiting
• Clinical Trial Site
  San Diego, California, United States Not yet recruiting
• Clinical Trial Site
  San Francisco, California, United States Not yet recruiting
• Clinical Trial Site
  Augusta, Georgia, United States Not yet recruiting
• Clinical Trial Site
  Lexington, Kentucky, United States Not yet recruiting

Study contacts

• Study coordinator: Alnylam Clinical Trial Information Line
• Email: clinicaltrials@alnylam.com
• Phone: 1-877-ALNYLAM

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Endothelial colony-forming cell behavior in people with von Willebrand disease and acquired von Willebrand syndrome

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• VONVENDI treatment for adults in China with von Willebrand disease

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• Assessing HMB-002 for treating Von Willebrand Disease

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.