Clinical Trial: A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome: Percentage of participants with CIN2/CIN3 associated with HPV16 single infection who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision [ Time Frame: Month 6 ]

Original Primary Outcome: Histologic resolution [ Time Frame: at month 6 ]

Current Secondary Outcome:

  • Percentage of participants who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision [ Time Frame: Months 6 ]
  • Percentage of participants who achieved Histologic response (Defined as CIN Grade less than [<] 2), determined by evaluation of tissue derived from surgical excision [ Time Frame: Month 6 ]
  • Percentage of participants with viral clearance based on Roche Linear assay results [ Time Frame: Months 3 and 6 ]
  • Percentage of participants with immunologic response to HPV antigens [ Time Frame: Day 1 (predose), Days 8, 15, and 29, Months 3 and 6 ]
  • Percentage of Participants with at least one Adverse Events (AEs) [ Time Frame: Up to Month 30 ]


Original Secondary Outcome:

  • Viral clearance by Roche HPV genomic testing [ Time Frame: at month 6 ]
  • Immunological response to HPV antigens [ Time Frame: after treatment and at intervals during follow-up ]
  • Safety and tolerability: adverse events, laboratory parameters [ Time Frame: Day 1 to Month 6, and at intervals during the 2 years of follow-up ]


Information By: Hoffmann-La Roche

Dates:
Date Received: November 20, 2009
Date Started: August 2009
Date Completion:
Last Updated: August 11, 2016
Last Verified: August 2016