HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age16-45
SponsorAlnylam Pharmaceuticals
About 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
Eligibility criteria
Qualifiers
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
Disqualifiers
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/1.73m² at screening
Is not willing to comply with the contraceptive requirements during the study period
Trial design
Treatments tested in this trial
- ALN-6400
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov