Viewing Study NCT01022346



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Last Modification Date: 2024-10-26 @ 10:13 AM
Study NCT ID: NCT01022346
Status: COMPLETED
Last Update Posted: 2016-08-15
First Post: 2009-11-20

Brief Title: A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia CIN Associated With High Risk Human Papillomavirus HR-HPV Infection
Sponsor: Hoffmann-La Roche
Organization: Hoffmann-La Roche

Study Overview

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 107 PFU RO5217790 in Patients With High Grade Cervical Intraepithelial Neoplasia Grade 2 or 3 Associated With High Risk HPV Infection
Status: COMPLETED
Status Verified Date: 2016-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 25 years
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2008-006946-24 EUDRACT_NUMBER None None