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HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB

ConditionsVon Willebrand Disease (VWD)Heavy Menstrual Bleeding (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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ALN-6400

    Drug

    ALN-6400 will be administered subcutaneously (SC).

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: ALN-6400 (Treatment Group A)Experimental treatment 1 intervention
Group B: ALN-6400 (Treatment Group B)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of Adverse Events

Time frame
Up to Week 72

Secondary outcomes

1

Change from Baseline in Plasminogen (PLG) Plasma Activity Levels

Time frame
Screening and up to Week 72 postdose
2

Change from Baseline in PLG Plasma Protein Levels

Time frame
Screening and up to Week 72 postdose
3

Change from Baseline in Menstrual Blood Loss Via Pictorial Blood Assessment Chart (PBAC)

Time frame
Screening and up to Week 72 postdose
4

Patient-reported Outcome (PRO) assessed by Patient Global Impression of Change (PGI-C) Score

Time frame
Week 4 up to Week 72

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alnylam Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: