Spots Global Cancer Trial Database for A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) Infection
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Trial Identification
Brief Title: A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) Infection
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study of the Safety and Response Rate of 3 Subcutaneously Administered Doses of 5 X 10^7 PFU RO5217790 in Patients With High Grade Cervical Intraepithelial Neoplasia Grade 2 or 3 Associated With High Risk HPV Infection
Study ID: NCT01022346
Conditions
Study Description
Brief Summary: This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
, Mobile, Alabama, United States
, Phoenix, Arizona, United States
, Phoenix, Arizona, United States
, Tucson, Arizona, United States
, Tucson, Arizona, United States
, Colton, California, United States
, Los Angeles, California, United States
, Colorado Springs, Colorado, United States
, Stamford, Connecticut, United States
, Washington, District of Columbia, United States
, Lake Worth, Florida, United States
, Miami, Florida, United States
, Plantation, Florida, United States
, Sarasota, Florida, United States
, South Miami, Florida, United States
, West Palm Beach, Florida, United States
, Atlanta, Georgia, United States
, Augusta, Georgia, United States
, Decatur, Georgia, United States
, Marrero, Louisiana, United States
, Framingham, Massachusetts, United States
, Kansas City, Missouri, United States
, Lincoln, Nebraska, United States
, Las Vegas, Nevada, United States
, Las Vegas, Nevada, United States
, Lawrenceville, New Jersey, United States
, Brightwaters, New York, United States
, Bronx, New York, United States
, New Bern, North Carolina, United States
, Winston-salem, North Carolina, United States
, Englewood, Ohio, United States
, Gallipolis, Ohio, United States
, Oklahoma City, Oklahoma, United States
, West Reading, Pennsylvania, United States
, Columbia, South Carolina, United States
, Greenville, South Carolina, United States
, Myrtle Beach, South Carolina, United States
, Nashville, Tennessee, United States
, Austin, Texas, United States
, Houston, Texas, United States
, McAllen, Texas, United States
, Sandy, Utah, United States
, Norfolk, Virginia, United States
, Antwerpen, , Belgium
, Brussel, , Belgium
, Bruxelles, , Belgium
, Edegem, , Belgium
, Gent, , Belgium
, Leuven, , Belgium
, Tienen, , Belgium
, Hus, , Finland
, Kuopio, , Finland
, Oulu, , Finland
, Tampere, , Finland
, Bordeaux, , France
, Dijon, , France
, Nantes, , France
, Paris, , France
, Reims, , France
, Strasbourg, , France
, San Juan, , Puerto Rico
, San Juan, , Puerto Rico
, Bilbao, Vizcaya, Spain
, Barcelona, , Spain
, Madrid, , Spain
, Madrid, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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