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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00038714
Other study ID # Stressgen SGN-00101-0005
Secondary ID SGN-00101-0005
Status Completed
Phase Phase 2
First received June 4, 2002
Last updated June 26, 2007
Start date November 2001
Est. completion date January 2004

Study information

Verified date June 2007
Source Nventa Biopharmaceuticals Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date January 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 18 Years
Eligibility 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:

- 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
SGN-00101


Locations

Country Name City State
United States Children's Hospital of Alabama Birmingham Alabama
United States University Hospitals of Cleveland Cleveland Ohio
United States University of Texas, Southwestern Medical School Dallas Texas
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Nemour's Childrens Clinic, Division of Pediatric Oncology Jacksonville Florida
United States University of Arkansas for Medical Sciences, Arkansas Children's Hospital Little Rock Arkansas
United States Fairview University Medical Center, University of Minnesota Minneapolis Minnesota
United States Children's Hospital of the King's Daughters Norfolk Virginia

Sponsors (1)

Lead Sponsor Collaborator
Nventa Biopharmaceuticals Corporation

Country where clinical trial is conducted

United States, 

See also
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Recruiting NCT06412172 - The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis (pRRP)
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