Hemophilia A and BNCT07421154
Study of a Smart Sharps Disposal Device in Patients With Hemophilia
A study testing 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. in people with Hemophilia A and B, run by University of Pennsylvania at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemophilia A and B
- What is being tested?
- 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.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Primary Investigator, 215-615-6555, Allyson.Pishko@pennmedicine.upenn.edu
Karen Panckeri, MBE, 215-615-6555, Karen.Panckeri@pennmedicine.upenn.edu
Penn Blood Disorders Program
Philadelphia, Pennsylvania, 19130-3805
About this study
Official title: Study of a Smart Sharps Disposal 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.
Read the detailed description
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.
- Conditions
- Hemophilia A and B
- Being tested
- 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.
- Keywords
- hemophilia
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention of being given device to use | Experimental | needle disposal device Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
% from baseline to active phase that patient adheres to using needle disposal
Measured: Days 1-180
Secondary outcomes (1)
Patient and provider satisfaction survey
Patient and provider satisfaction survey
Measured: Day 181 +/- 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia A and BStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Everyone gets a Sharps needle disposal device.
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Sharpscue
- Responsible party
- Principal investigator, Allyson Pishko, University of Pennsylvania
- Investigators
- Allyson Pishko, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421154
- Sponsor's protocol ID
- 851363
- Status last verified
- Apr 2026
- First submitted
- 9 Feb 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Request for de-identified data will be reviewed by PI
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Smart Sharps Disposal in Patients With Hemophilia
- ClinicalTrials.gov ID
- NCT07421154
- Acronym / sponsor ID
- 851363
- Conditions
- Hemophilia A and B
- Keywords
- hemophilia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Sharpscue
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Everyone gets a Sharps needle disposal device.
| Arm | Type | Receives |
|---|---|---|
| intervention of being given device to use | Experimental | 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.needle disposal device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.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 | intervention of being given device to use |
Primary outcome
Adherence
Time frame: Days 1-180
% from baseline to active phase that patient adheres to using needle disposal
1 secondary outcome
Patient and provider satisfaction survey
Time frame: Day 181 +/- 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. Request for de-identified data will be reviewed by PI
Related trials for Hemophilia A and B
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
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RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia
RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allyson Pishko, MD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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. in people with Hemophilia A and B, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allyson Pishko, MD (215-615-6555, Allyson.Pishko@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Days 1-180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.