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A Study of RO5217790 (HPV Targeted Immunotherapy) in Patients With High Grade Cervical Intraepithelial Neoplasia Associated With High Risk HPV Infection - NCT01022346-35233(Clinical Trial 424440)



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City:  Birmingham
State:  
AL
Zip Code: 35233
Conditions: Cervical Intraepithelial Neoplasia
Purpose: This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in patients with high grade cervical intraepithelial neoplasia associated with high risk HPV infection. Patients will be randomized to receive 3 sc injections of either placebo or RO5217790 on days 1, 8 and 15. Histologic and viral assessments will be made at baseline, at month 3 and 6, and every 6 months thereafter for an overall of 2.5 years. Target sample size is 200 patients.
Study summary:
Criteria: Inclusion Criteria: - females >/= 18 years of age - diagnosis of CIN 2/3 within 2 months prior to study entry confirmed by colposcopy-directed punch biopsy - patients must have at least 1 quadrant of residual CIN 2/3 disease remaining after biopsy - single or multiple HR-HPV infection at screening by analysis of liquid based cytology material by Roche HPV genomic testing Exclusion Criteria: - colposcopically visible CIN 2/3 disease extending over more than 2 quadrants - previous excisional or ablative surgical treatment for CIN - any anatomical condition of the cervix that would interfere with a complete evaluation of the transformation zone and surveillance of CIN - vulvar(VIN) or vaginal (VAIN) intraepithelial neoplasia - atypical endometrial or glandular cells or evidence of carcinoma on biopsy - proven or suspected immunosuppressive disorder or autoimmune disease
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Data Source: ClinicalTrials.gov
Date Processed: January 6, 2011
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