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NCT Number: NCT07421154

Study of a Smart Sharps Disposal Device in Patients With Hemophilia

This pilot study will have patients use a smart sharps disposal container at home for disposal of needles used to administer their hemophilia drugs. The study aims to find out if the smart sharps container proved acceptable to use by patients and medical providers and can be adhered to.

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Key information

Conditions

Hemophilia A and B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

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About this study

Preventative factor or non-factor product IV administration has been shown to improve outcomes in patients with hemophilia. The need for patients to log their doses or complete questionnaires can be burdensome. This study seeks to use novel technology, a smart sharps container that records disposal of the needle used to administer preventive products. We will perform a prospective study of adult patients with hemophilia A/B who are on factor or non-factor products. They will all be given the device to take home and use there.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Male or female, ≥18 years of age
  • Moderate or Severe Hemophilia A or B, with or without an inhibitor
  • Prescribed prophylaxis with either a factor product or emicizumab that is scheduled to be given at least once every 14 days

Exclusion:

  • Stated inability to use the SharpsCue container
  • Treatment with another investigational drug or other intervention during the study period
  • Patients on prophylactic dosing less than once every 14 days
  • Patients who are infused by a home nurse

Treatment and study plan

The smart Sharps device is given to the patient and they use it to throw needles away in. It is not internal to the patient.

Other

The smart Sharps device is given to the patient and they use it to throw needles away in. It is not internal to the patient.

Primary outcomes

  1. Adherence

    Time frame: Days 1-180

    % from baseline to active phase that patient adheres to using needle disposal

Secondary outcomes

  1. Patient and provider satisfaction survey

    Time frame: Day 181 +/- 7 days

    Patient and provider satisfaction survey

Study contacts

Contact information is provided by the study sponsor or research team.

Allyson Pishko, MD

CONTACT

[email protected]

215-615-6555

Karen Panckeri, MBE

CONTACT

[email protected]

215-615-6555

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Sharpscue

Registry information

Official study title

Study of a Smart Sharps Disposal in Patients With Hemophilia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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