Confirmatory Study of PRGN-2012 in Patients with RRP

Description

The purpose of this confirmatory study is to provide further demonstration of the efficacy of PRGN-2012 for the treatment of RRP in adults.

Conditions

Recurrent Respiratory Papillomatosis, Papillomavirus Infection, Papillomaviridae

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Study Overview

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Study Details

Study overview

The purpose of this confirmatory study is to provide further demonstration of the efficacy of PRGN-2012 for the treatment of RRP in adults.

A Phase 3 Trial of PRGN-2012 for the Treatment of Recurrent Respiratory Papillomatosis in Adult Patients

Confirmatory Study of PRGN-2012 in Patients with RRP

Condition
Recurrent Respiratory Papillomatosis
Intervention / Treatment

-

Contacts and Locations

Bethesda

National Institute of Health, Bethesda, Maryland, United States, 20892

Cincinnati

University of Cincinnati, Cincinnati, Ohio, United States, 45267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 18 years and older
  • * Clinical diagnosis of RRP requiring surgical intervention
  • * Performance status of ECOG of 0-1
  • * Sexually active participants (men and women) of reproductive potential must agree to use contraception.
  • * All participants must have the ability to understand and willingness to sign a written informed consent
  • * Severe acute or chronic medical or psychiatric conditions that, in the opinion of the investigators, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results and in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • * Participants receiving any prohibited medications including immunosuppressive medications and other treatments for RRP.
  • * Participants who had received any other investigational agents within the past 30 days.
  • * Pregnant women are excluded from this study

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Precigen, Inc,

Amy Lankford, PhD, STUDY_DIRECTOR, Precigen, Inc

Study Record Dates

2029-03-01