A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) Infection
NCT ID: NCT01022346
Last Updated: 2016-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
206 participants
INTERVENTIONAL
2009-08-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15.
Placebo
Placebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15.
RO5217790
RO5217790 will be administered at a dose of 5\*10\^7 plaque forming unit (pfu) subcutaneously on Days 1, 8, and 15.
RO5217790
RO5217790 will be administered at a dose of 5\*10\^7 pfu subcutaneously on Days 1, 8, and 15.
Interventions
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Placebo
Placebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15.
RO5217790
RO5217790 will be administered at a dose of 5\*10\^7 pfu subcutaneously on Days 1, 8, and 15.
Eligibility Criteria
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Inclusion Criteria
* Have satisfactory colposcopy, i.e. the entire acetowhite or disease area as well as the entire squamocolumnar junction visualized by colposcopy
* Have detection at screening of a single or multiple HR-HPV infection by analysis of liquid based cytology (LBC) material on the Roche Linear Array assay consistent with any of the trial strata as specified in study protocol
Exclusion Criteria
* Have any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the transformation zone and surveillance of CIN. If an endocervical curettage (ECC) is performed, and the endocervical curettings reveal CIN, patients are eligible as long as the endocervical lesion is directly extending from the primary lesion and is colposcopically visible in its entirety
* Have vulvar (VIN) or vaginal (VAIN) intraepithelial neoplasia
* Have atypical endometrial or glandular cells or evidence of carcinoma on biopsy
* Have a serious, concomitant disorder, including active systemic infection requiring treatment
* Have a prior history of or current malignancy other than adequately treated skin cancer (squamous cell cancer or basal cell carcinoma), unless the history of skin cancer is at the site of study treatment administration
* Have a proven or suspected immunosuppressive disorder or autoimmune disease
* Have any significant cardiac, hepatic or renal disease
* Have active viral infections including human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), cytomegalovirus (CMV), and Epstein barr virus (EBV) within 30 days of receiving study treatment. Mild viral infections such as Herpes Simplex Virus 1 (HSV-1) or common cold are not excluded
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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 D.C., 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
The 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 City, Utah, United States
Norfolk, Virginia, United States
Antwerp, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Ghent, , 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
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Bilbao, Vizcaya, Spain
Countries
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Other Identifiers
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2008-006946-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NV25025
Identifier Type: -
Identifier Source: org_study_id
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