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CompletedNCT00038714Updated Jun 27, 2007

A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis

A Phase 2 interventional study of SGN-00101 in Papilloma and Recurrent Respiratory Papillomatosis, sponsored by Nventa Biopharmaceuticals Corporation. Completed at 8 sites in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2007-06-27.

Sponsored by Nventa Biopharmaceuticals Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
2 Years to 18 Years
Sex
All
01

Study summary

Recurrent Respiratory Papillomatosis (RRP) causes wart-like lesions along the throat area and can obstruct the airway or become malignant. The cause has been related to specific types of Human Papillomavirus (HPV). The purpose of the study is to assess the clinical effectiveness of a trial drug, SGN-00101, in children with RRP and also assess its safety.

02

Conditions studied

  • Papilloma
  • Recurrent Respiratory Papillomatosis

Keywords

  • HPV
  • Papilloma
03

In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's planned enrollment of 27 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Nventa Biopharmaceuticals Corporation is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female between 2 and 18 yrs old, inclusive, who has documented RRP.
  • Patients with documented RRP
  • Subject is surgically debulked within 7 days before the first dose of SGN-00101.
  • Subject has had at least 4 debulking surgeries for RRP, had no intersurgical intervals greater than 84 days during the period of the last 4 surgeries.
  • Subject is free of life threatening or serious concomitant disorders other than the disease under study.
  • Females of childbearing potential must have a negative pregnancy test and must be practicing an effective/appropriate method of birth control as determined by the Investigator.

Exclusion criteria

Exclusion Criteria:

  • Subject has disease or status that causes compromise of the immune system.
  • Subject has a history of ionizing radiation therapy to the respiratory tract.
  • Patient has used concomitant medications that may suppress the immune system.
  • Subject has received any specific or non-specific immunotherapy intended as treatment for their RRP (i.e. mumps vaccine injected intralesionally) within 9 months prior to Week 0 of this study.
  • Subject has participated in a past study with SGN-00101
  • Pregnancy and lactation.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (estimated)

Interventions

  • DrugSGN-00101
06

Study locations

8 sites
  • Children's Hospital of Alabama
    Birmingham, Alabama 35233, United States
  • University of Arkansas for Medical Sciences, Arkansas Children's Hospital
    Little Rock, Arkansas 72202, United States
  • Nemour's Childrens Clinic, Division of Pediatric Oncology
    Jacksonville, Florida 32207, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • Fairview University Medical Center, University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • University Hospitals of Cleveland
    Cleveland, Ohio 44106, United States
  • University of Texas, Southwestern Medical School
    Dallas, Texas 75390, United States
  • Children's Hospital of the King's Daughters
    Norfolk, Virginia 23507, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00038714
Lead sponsor
Nventa Biopharmaceuticals Corporation
First posted
Jun 5, 2002
Start date
Nov 2001
Completion
Jan 2004
Last update
Jun 27, 2007
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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