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Thrombolytic Agent

Treatment-inhaled tPA for Plastic Bronchitis (PLATyPuS Trial)

Phase 2
Waitlist Available
Led By Kathleen A Stringer, PharmD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up episodes of cast production will be assessed daily for the duration tpa treatment, up to 4 days and from hospital discharge (~1 week after treatment) up to 30 days
Awards & highlights

PLATyPuS Trial Summary

This trial is testing the safety and efficacy of using inhaled tissue plasminogen activator (tPA) to treat children with plastic bronchitis, a rare disease characterized by the formation of obstructive airway casts.

Eligible Conditions
  • Plastic Bronchitis
  • Protein-Losing Enteropathy
  • Healthy Subjects

PLATyPuS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~episodes of cast production will be assessed daily for the duration tpa treatment, up to 4 days and from hospital discharge (~1 week after treatment) up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and episodes of cast production will be assessed daily for the duration tpa treatment, up to 4 days and from hospital discharge (~1 week after treatment) up to 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Endpoint: Number of Subjects That Develop New, Active Bleeding
Secondary outcome measures
Arterial Oxygen Saturation (%)
Assessment of Patient Centered Outcomes
Changes in the Chest X-ray (CXR)
+8 more

PLATyPuS Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment-inhaled tPAExperimental Treatment1 Intervention
All patients with plastic bronchitis enrolled into the study will receive inhaled tPA.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment-inhaled tPA
2018
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,859 Total Patients Enrolled
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,378,018 Total Patients Enrolled
Kathleen A Stringer, PharmDPrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies for participants in this research?

"Yes, the clinicaltrials.gov database shows that this medical study is actively seeking volunteers. It was initially introduced on March 19th 2018 and updated lastly on June 2nd 2022. The team requires 13 participants from 4 different sites for their research project."

Answered by AI

Can you provide information about previous experiments with Treatment-inhaled tPA?

"Initially trialled at Geisinger Wyoming Valley Medical Center in 2017, the medication treatment-inhaled tPA has seen 73 completed studies. Currently there are 22 active trials with a significant concentration in Cincinnati, Ohio."

Answered by AI

What is the prevalence of this experiment in North American facilities?

"There are 4 physical sites enrolling participants in this trial. They can be found in Cincinnati, Ann Arbor, and Philadephia as well as a few other cities. To make the process easier it is recommended to select a location that is closest geographically to lessen travel-related exhaustion."

Answered by AI

Is the cut-off age for this research trial set at 65 years or higher?

"This clinical trial specifically requires that patients are between 5 and 24 years old to be eligible. Additionally, there are 88 trials for minors as well as 453 studies targeting seniors."

Answered by AI

What is the uppermost number of participants in this research experiment?

"Affirmative. The clinical trial is still enrolling as per the records available on clinicaltrials.gov, which were first posted on March 19th 2018 and last updated June 2nd 2022. A total of 13 patients will be recruited from 4 different medical sites to participate in this study."

Answered by AI

To whom does this medical trial offer participation?

"This clinical trial is seeking to enrol 13 people aged between 5 and 24 with protein-losing enteropathies. Eligible participants must meet additional requirements such as having the capacity to use a mouthpiece nebulizer, being able to provide informed consent (or assent if under 14 years old) and weighing at least 18.6 kgs (41 lbs). Additionally, those diagnosed with CHD who have experienced an acute exacerbation of PB or pathologic evidence of fibrin airway cast production will also be considered eligible for this trial."

Answered by AI

What precautions should be observed when administering Treatment-inhaled tPA to patients?

"Since Treatment-inhaled tPA is only in the second phase of trials, there has been no proof of efficacy yet. Thus, its safety rating on a scale from 1 to 3 comes out as 2 due to existing data suggesting that it may be safe for use."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Inhaled Tissue Plasminogen Activator for Acute Plastic Bronchitis
Kathleen A. Stringer 2018. "Inhaled Tissue Plasminogen Activator for Acute Plastic Bronchitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02315898.
~6 spots leftby Apr 2025
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