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PRGN-2012 for Respiratory Papillomatosis
Study Summary
This trial is for people with a rare disease called Recurrent Respiratory Papillomatosis who need lots of surgery to manage it. The disease is caused by HPV.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I've had surgery to remove skin growths and can't safely wait six weeks between treatments.I have growths in my throat or windpipe, with or without lung involvement.I agree to use two forms of birth control during and for 4 months after vaccine treatment.I have a serious heart condition.You do not have hepatitis C, unless further testing shows that the virus is not present in your blood.My organs and bone marrow are functioning well.I do not have severe medical or mental health issues that could make the study risky for me.I have had 3 or more treatments for RRP in the last year.I have side effects from past treatments, but they are mild and not dangerous.My papilloma diagnosis is confirmed by a certified lab report.I do not have active hepatitis B according to tests.I am 18 years old or older.I have been diagnosed with recurrent respiratory papillomatosis.I haven't taken steroids or immune-suppressing drugs in the last 14 days.I have had immunotherapy for RRP before.I haven't taken any systemic therapy for my condition in a time equal to three half-lives of the last drug I used, or 30 days for bevacizumab.I am fully active or can carry out light work.I am willing to have endoscopic exams and surgeries as required.You have a history of alcohol or drug abuse.
- Group 1: Adjuvant PRGN-2012
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What aims is this research endeavor hoping to fulfill?
"The main aim of this research project, assessed over the course of about a month, is to establish what proportion of patients have their surgery-free duration extended after undergoing adjuvant treatment with PRGN-2012. Secondary goals include: calculating the rate (and 95% confidence intervals) of pulmonary RRP complete and partial responses in those participants treated for pulmonary diseases; assessing if there is a statistically significant difference between pre/post treatment surgery frequency across all individuals receiving care; and again determining the percentage (alongside 95% confidence intervals) of lung related RRP partial and total successes among those given therapy."
Is enrollment for this experiment open at the moment?
"Affirmative. Clinicaltrials.gov reveals that this research endeavour, which was first announced on March 16th 2021, is actively seeking participants. A total of 48 patients are being recruited from a single location."
What is the upper limit of participants for this medical experiment?
"Affirmative. The clinicaltrials.gov records reveal that this research venture, which was initially posted on March 16th 2021, is currently in its recruitment phase. 48 volunteers will be enrolled at a single study location."
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