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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01022346

Public ClinicalTrials.gov record NCT01022346. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 Grade Cervical Intraepithelial Neoplasia Grade 2 or 3 Associated With High Risk HPV Infection

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01022346
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
206 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2009 (Type not available)
Primary completion
Sep 2013 (Actual)
Completion
Sep 2013 (Actual)
Last update posted
Aug 15, 2016

2009 – 2013

United States locations

U.S. sites
43
U.S. states
24
U.S. cities
40
Facility City State ZIP Site status
Not listed Mobile Alabama 36608 —
Not listed Phoenix Arizona 85015 —
Not listed Phoenix Arizona 85032 —
Not listed Tucson Arizona 85712 —
Not listed Tucson Arizona 85724-5078 —
Not listed Colton California 92324 —
Not listed Los Angeles California 90027 —
Not listed Colorado Springs Colorado 80910 —
Not listed Stamford Connecticut 06904 —
Not listed Washington D.C. District of Columbia 20010 —
Not listed Lake Worth Florida 33461 —
Not listed Miami Florida 33136 —
Not listed Plantation Florida 33324 —
Not listed Sarasota Florida 34239 —
Not listed South Miami Florida 33143 —
Not listed West Palm Beach Florida 33409 —
Not listed Atlanta Georgia 30322 —
Not listed Augusta Georgia 30912 —
Not listed Decatur Georgia 30034 —
Not listed Marrero Louisiana 70072 —
Not listed Framingham Massachusetts 01702 —
Not listed Kansas City Missouri 64139 —
Not listed Lincoln Nebraska 68510 —
Not listed Las Vegas Nevada 89030 —
Not listed Las Vegas Nevada 89128 —
Not listed Lawrenceville New Jersey 08648 —
Not listed Brightwaters New York 11718 —
Not listed The Bronx New York 10461 —
Not listed New Bern North Carolina 28562 —
Not listed Winston-Salem North Carolina 27103 —
Not listed Englewood Ohio 45322 —
Not listed Gallipolis Ohio 45631 —
Not listed Oklahoma City Oklahoma 73104 —
Not listed West Reading Pennsylvania 19611 —
Not listed Columbia South Carolina 29201 —
Not listed Greenville South Carolina 29615 —
Not listed Myrtle Beach South Carolina 29572 —
Not listed Nashville Tennessee 37232 —
Not listed Austin Texas 78705 —
Not listed Houston Texas 77004 —
Not listed McAllen Texas 78503 —
Not listed Sandy City Utah 84070 —
Not listed Norfolk Virginia 23502 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01022346, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 15, 2016 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01022346 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →