A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5x10E7pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infectio

Phase 1

• Conditions: High grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infection; MedDRA version: 9.1Level: LLTClassification code 10049701Term: Cervical intraepithelial neoplasia II; MedDRA version: 9.1Level: LLTClassification code 10049702Term: Cervical intraepithelial neoplasia III

• Registration Number: EUCTR2008-006946-24-BE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-27
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Are greater than or equal to 18 years old
2. Have provided written informed consent
3. . Have a diagnosis within 60 days prior to the first dose of RO5217790 of CIN 2/3 confirmed by colposcopy-directed punch biopsy; patients must have at least 1 quadrant of residual CIN2/3 disease remaining after biopsy.
4. 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Have colposcopically visible CIN2/3 disease extending over more than 2 quadrants
2. Have had any previous excisional or ablative surgical treatment for CIN
3. Have vulvar (VIN) or vaginal (VAIN) intraepithelial neoplasia
4. Have atypical endometrial or glandular cells or evidence of carcinoma on biopsy
5. Have a proven or suspected immunosuppressive disorder or autoimmune disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified