Von Willebrand Disease (VWD)Heavy Menstrual Bleeding (HMB)
Investigational drug(s) / intervention(s)
ALN-6400
ALN-6400: ALN-6400 will be administered subcutaneously (SC).
Study 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
Sex
FEMALE
Min age
16 Years
Max age
45 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Frequency of Adverse Events — Up to Week 72
Trial sites (4)
Facility
City
Region
Status
Clinical Trial Site
Los Angeles
California
Recruiting
Clinical Trial Site
Orange
California
Recruiting
Clinical Trial Site
Miami
Florida
Recruiting
Clinical Trial Site
Lexington
Kentucky
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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